Nezve FDA
"Congress yakapa FDA simba rekudzora zvigadzirwa zvefodya kuburikidza nehunyanzvi hwesainzi kuchengetedza veruzhinji kubva kune zvinokuvadza zvinokonzerwa nefodya," akadaro Acting FDA Commissioner Janet Woodcock."Kuona kuti fodya itsva yaongororwa neFDA chinhu chakakosha pachinangwa chedu chekuderedza hurwere nerufu zvine chekuita nefodya. Tinoziva kuti fodya ine flavoured inokwezva zvikuru kune vechidiki, saka kuongorora kukanganisa kwefodya kana kushandiswa kwefodya chaiyo. vechidiki ndicho chinhu chakakosha pakuona kuti ndezvipi zvigadzirwa zvinogona kutengeswa."
Chiitiko ichi chinotaridza kufambira mberi kwakakosha mukugamuchira nhamba isati yamboonekwa yezvikumbiro pamberi pemusi waGunyana 9, 2020 wakatemerwa nedare rekupedzisira rekuisa zvikumbiro zvinonzi zvigadzirwa zvitsva zvefodya, pamwe nezuva rekupedzisira rekugadzirisa kushandiswa kwepwere.
FDA yatambira zvikumbiro kubva kumakambani anodarika mazana mashanu anobata fodya inodarika mamiriyoni matanhatu nemazana mashanu ezviuru.Kunyange iyo agency yakapa mamwe maitiro asina kunaka pane mamwe maapplication, iyi ndiyo yekutanga seti yeMdos iyo FDA yakapa kune zvikumbiro zvinosangana nechikamu chekuongorora chesainzi che premarket wongororo.Sangano rakazvipira kushandura musika uripo kuenda kumusika uko zvese zvigadzirwa zveENDS zviripo kutengeswa zvinoratidzwa kuti "zvakakodzera kuchengetedza hutano hweveruzhinji".
Musi waNyamavhuvhu 27, FDA yakazivisa kuti yakaramba 55,000 premarket fodya zvikumbiro (PMTAS) kubva kune vatatu vagadziri vefodya yefodya nekuti vakatadza kupa humbowo hwekuti vaidzivirira hutano hweveruzhinji.
Iyo FDA yakagamuchira ~ 6.5 miriyoni PMTA zvikumbiro zve-e-fodya nenguva yekupedzisira yaGunyana 9, ichisiya ~ 2 miriyoni zvikumbiro zvisina kuziviswa, kusanganisa ~ 4.5 miriyoni zvikumbiro (JD Nova Group LLC) izvo zvakamboziviswa sekunge zvisingaite zvinodiwa.Ne 55,000 zvikumbiro zvakarambwa panguva ino, isingasviki 1.95 miriyoni inoramba isina kuziviswa.Zvakare, zviito zveFDA zvinoratidza kuti inogona kusabvumidza chero e-fodya yemafuta ebhodhoro inonaka kunze kwefodya.Masvondo maviri nguva yenyasha isati yapera musi wa9 Gunyana 2021, izvi zvinogona kureva kuti dzinenge dzese dzasara dzePMTAS dzicharambwa.
Nhasi, US Food and Drug Administration yakapa yekutanga kushambadzira Denial orders (Mdos) yemagetsi Nicotine Delivery System (ENDS) zvigadzirwa mushure mekuona kuti zvikumbiro kubva kune vatatu vakanyorera kune zvingangoita zviuru makumi mashanu neshanu ezvigadzirwa zveENDS zvakashaya humbowo hwakakwana hwekubatsira kune vakuru vanoputa.Zvakakwana kukunda njodzi yehutano hweveruzhinji inounzwa nezvakanyorwa uye zvinotyisa mazinga ekushandiswa kwevechiri kuyaruka kwezvigadzirwa zvakadaro.JD Nova Group LLC, Great American Vapes uye Vapor Salon ndiwo maENDS asina fodya, Anosanganisira Apple Crumble, Dr. Cola uye Cinnamon Toast Cereal.
Flavored ENDS zvigadzirwa zvinoda humbowo hwakasimba
Zvigadzirwa zvinodikanwa kune PRE-musika application yeMDO zvinogona kusaunzwa kana kuendeswa kuitira kuunza kutengeserana pakati penyika.Kana chigadzirwa chacho chatova pamusika, chinofanira kubviswa pamusika kana pangozi yekumanikidzirwa.Iyo MDO yakaziviswa nhasi haisanganisi zvese ENDS zvigadzirwa zvakaunzwa nekambani;zvikumbiro zvevamwe zvichiri kutariswa.Iyo FDA yakambozivisa imwe yemakambani, JD Nova Group LLC, kuti chikumbiro chayo chefodya yepremarket ine chekuita nezvigadzirwa zvayo zvinosvika miriyoni 4.5 haina kuzadzisa zvinodiwa pakunyorera chigadzirwa chitsva chefodya ichitsvaga mvumo yekushambadzira.
"The flavoured ENDS zvigadzirwa zvinofarirwa zvikuru nevechidiki, uye vanopfuura 80 muzana yevashandisi vefodya vane makore gumi nemaviri kusvika ku17 vachishandisa chimwe chezvigadzirwa izvi. "Makambani ari kuda kuenderera mberi nekutengesa zvigadzirwa zvawo zveENDS zvakasarudzika anofanirwa kunge aine humbowo hunovimbika hwekuti zvinogona kubatsira. zvezvigadzirwa zvavo zvevasvuti vakura zvinokurira ngozi dzinozivikanwa kupwere dzakura,” akadaro Mitch Zeller, mutungamiriri weFDA’s Center for Tobacco Products. Basa riri pavanyoreri kupa ufakazi hwokuti kutengeswa kwezvigadzirwa zvavo kunoenderana nemutemo we“zvakakwana. kuchengetedzwa kwehutano hweveruzhinji". Kana pasina humbowo hwakakwana kana husina kukwana, FDA inotarisira kupa chirevo chekuramba kushambadzira chinoda kuti chigadzirwa chibviswe pamusika kana kubviswa pamusika.
FDA inoyambira zvinopfuura mamirioni gumi nemashanu zvigadzirwa
Pakupera kwemwedzi wapera, FDA yakayambira makambani ane zvigadzirwa zvinopfuura mamirioni gumi neshanu kuti abvise zvisiri pamutemo zvigadzirwa zvefodya pamusika:
Iyo FDA nhasi yaburitsa tsamba yambiro kukambani inotengesa zvigadzirwa zvefodya zvakanyorwa neFDA, zvinosanganisira akawanda e-liquids, yekutengesa zvisiri pamutemo kwemagetsi Nicotine Delivery System (ENDS) zvigadzirwa pasina rezinesi.Chiitiko ichi chinoratidza kuzvipira kuri kuita sangano iri mukuona kuti fodya inotengeswa yatevedza mutemo kuitira kuchengetedza vechidiki pamwe nehutano hweveruzhinji.
Matsamba echenjedzo aya mhedzisiro yekuongorora nekutariswa kuri kuramba kuchiitwa paInternet kana paine kutyorwa kwemitemo nemirau yefodya.FDA inoda kuti vagadziri vese nevatengesi vefodya vazive kuti tinoenderera mberi nekutarisa musika nekuona kuti makambani ane mhosva yekutyora mutemo.
FDA icharamba ichiisa pamberi pemakambani anotengesa ENDS pasina mvumo inodiwa uye haana kuisa premarket application kune agency, kunyanya ayo anogona kushandisa kana kutanga zvigadzirwa zvevachiri kuyaruka.
Nhasi, iyo FOOD neDrug Administration yakatumira tsamba yambiro kuVisible Vapors LLC, kambani yePennsylvania-based inogadzira uye inoshanda webhusaiti yekutengesa electronic nicotine Delivery System (ENDS) zvigadzirwa,
kusanganisira e-cigarettes uye e-liquids, achivaudza kuti, Hazvisi pamutemo kutengesa fodya mitsva iyi pasina mvumo yepamberi, saka haigone kutengeswa kana kugoverwa muUnited States.Iyo kambani haina kuendesa chero premarket Chigadzirwa Chigadzirwa application (PMTA) nemusi wa9 Gunyana 2020.
Kutanga Nyamavhuvhu 8, 2016, premarket yekuongorora zvikumbiro zvezvimwe zvigadzirwa zvefodya zvinoonekwa sezvitsva, zvinosanganisira e-fodya uye e-zvinwiwa, zvinofanirwa kuendeswa kuFDA naGunyana 9, 2020, sekureva kwedare.
Tsamba yambiro yakapihwa nhasi yakataura zvigadzirwa, zvinosanganisira Visible Vapors Irish Potato 100mL uye Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, Iyo kambani ine zvigadzirwa zvinopfuura mamirioni gumi neshanu zvakanyorwa neFDA uye inofanirwa kuona kuti zvigadzirwa zvayo zvese zvinoenderana. federal mitemo, kusanganisira premarket ongororo zvinodiwa.
Zvinoenderana nezvakaiswa pamberi peiyo agency, mushure meGunyana 9, 2020, FDA ichaisa pamberi pekushandisa kune chero chigadzirwa cheENDS chinoramba chichitengeswa uye chisati chagamuchira chigadzirwa application.
Pakati paNdira naChikumi 2021, iyo FDA yakatumira tsamba zana nemakumi matatu neimwe yambiro kumakambani ari kutengesa kana kugovera anopfuura zviuru zana nemakumi mana nemakumi manomwe ezviuru zveENDS zvisina kuendesa zvikumbiro zvezvigadzirwa izvi pakupera kwaGunyana 1,470,000.
Makambani anogashira tsamba yambiro kubva kuFDA anofanirwa kutumira mhinduro yakanyorwa mukati memazuva gumi nemashanu ekushanda mushure mekugamuchira tsamba inotaura chiito chekambani chekugadzirisa, kusanganisira zuva rakaregwa kukanganisa uye / kana zuva rakagoverwa chigadzirwa.Vanodawo kuti makambani arambe achitevedzera zvirongwa zvemangwana pasi peFederal Food, Drug and Cosmetic Act
Nguva yekutumira: Oct-15-2021
