Hais txog FDA
"Lub Rooj Sab Laj tau tso cai rau FDA los tswj cov khoom lag luam luam yeeb los ntawm kev saib xyuas kev tshawb fawb los tiv thaiv pej xeem los ntawm kev phom sij ntawm kev siv luam yeeb," Tus Thawj Saib Xyuas Kev Noj Qab Haus Huv ntawm FDA Janet Woodcock tau hais."Kev ua kom ntseeg tau tias cov khoom lag luam luam yeeb tshiab raug soj ntsuam los ntawm FDA yog ib feem tseem ceeb ntawm peb lub hom phiaj ntawm kev txo qis kev haus luam yeeb txog kev mob thiab kev tuag. Peb paub tias cov khoom lag luam luam yeeb muaj txiaj ntsig zoo rau cov tub ntxhais hluas, yog li kev ntsuas qhov cuam tshuam ntawm qhov muaj peev xwm lossis kev siv yeeb tshuaj tiag tiag ntawm cov tub ntxhais hluas yog qhov tseem ceeb hauv kev txiav txim siab cov khoom twg tuaj yeem muag tau. "
Qhov kev nqis tes no ua rau muaj kev vam meej tseem ceeb hauv kev tau txais cov ntawv thov uas tsis tau muaj dua ua ntej lub Cuaj Hlis 9, 2020 lub tsev hais plaub tau txiav txim hnub kawg rau kev ua ntawv thov ua ntej muag khoom lag luam, nrog rau lub sijhawm kawg los hais txog cov tub ntxhais hluas siv cov khoom qab zib.
FDA tau txais cov ntawv thov los ntawm ntau dua 500 lub tuam txhab uas suav nrog ntau dua 6.5 lab cov khoom lag luam luam yeeb.Thaum lub koom haum tau tshaj tawm lwm qhov tsis zoo rau qee daim ntawv thov, qhov no yog thawj txheej ntawm Mdos FDA tau tshaj tawm rau cov ntawv thov uas ua tau raws li qhov tseem ceeb ntawm kev tshuaj xyuas kev tshawb fawb ntawm kev tshuaj xyuas ua ntej.Lub koom haum tau cog lus rau kev hloov pauv kev lag luam tam sim no mus rau lub lag luam uas txhua yam khoom ENDS muaj muag tau pom tias yog "tsim los tiv thaiv pej xeem kev noj qab haus huv".
Thaum Lub Yim Hli 27, FDA tau tshaj tawm tias nws tau tsis lees txais 55,000 daim ntawv thov luam yeeb ua ntej (PMTAS) los ntawm peb tus tsim hluav taws xob e-luam yeeb vim tias lawv tsis muab pov thawj tias lawv tiv thaiv kev noj qab haus huv rau pej xeem.
FDA tau txais ~ 6.5 lab PMTA daim ntawv thov rau e-luam yeeb los ntawm lub Cuaj Hlis 9 lub sijhawm kawg, tawm mus ~ 2 lab daim ntawv thov tsis tau tshaj tawm, tsis suav nrog ~ 4.5 lab daim ntawv thov (JD Nova Group LLC) uas yav dhau los tau ceeb toom tias tsis ua raws li qhov yuav tsum tau ua.Nrog 55, 000 daim ntawv thov tsis lees paub lub sijhawm no, tsawg dua 1.95 lab tseem tsis tau tshaj tawm.Dab tsi ntxiv, FDA qhov kev ua tau qhia tias nws yuav tsis pom zoo rau cov roj e-luam yeeb uas saj lwm yam tshaj li luam yeeb.Ob lub lis piam ua ntej lub sijhawm kev tshav ntuj xaus rau lub Cuaj Hlis 9, 2021, qhov no tuaj yeem txhais tau tias yuav luag tag nrho PMTAS uas tseem tshuav yuav raug tsis lees paub.
Niaj hnub no, US Food and Drug Administration tau tshaj tawm thawj qhov kev txiav txim siab tsis kam lees (Mdos) rau cov khoom siv hluav taws xob Nicotine Delivery System (ENDS) tom qab txiav txim siab tias cov ntawv thov los ntawm peb tus neeg thov rau kwv yees li 55,000 cov khoom qab zib ENDS tsis muaj pov thawj txaus ntawm cov txiaj ntsig rau cov neeg laus haus luam yeeb.Txaus los kov yeej cov pej xeem kev noj qab haus huv kev hem thawj los ntawm cov ntaub ntawv thiab ceeb toom ntawm cov tub ntxhais hluas siv cov khoom no.JD Nova Group LLC, Great American Vapes thiab Vapor Salon yog qhov tsis haus luam yeeb ENDS, Lawv suav nrog Apple Crumble, Dr. Cola thiab Cinnamon Toast Cereal.
Flavored ENDS cov khoom lag luam xav tau cov ntaub ntawv pov thawj
Cov khoom lag luam xav tau rau daim ntawv thov kev lag luam PRE rau MDO yuav tsis raug qhia lossis xa tawm txhawm rau qhia txog kev lag luam hauv xeev.Yog hais tias cov khoom twb nyob rau hauv kev ua lag luam, nws yuav tsum tau muab tshem tawm los ntawm lub khw los yog muaj kev pheej hmoo ntawm kev tswj hwm.MDO tshaj tawm hnub no tsis suav nrog tag nrho cov khoom ENDS xa los ntawm lub tuam txhab;daim ntawv thov rau lwm qhov tseem tab tom xav txog.FDA yav dhau los tau ceeb toom rau ib lub tuam txhab, JD Nova Group LLC, tias nws daim ntawv thov kev lag luam luam yeeb ua ntej muaj feem cuam tshuam rau nws kwv yees li 4.5 lab cov khoom lag luam tsis tau raws li daim ntawv thov rau cov khoom luam yeeb tshiab nrhiav kev tso cai ua lag luam.
"Cov khoom qab zib ENDS nrov heev rau cov tub ntxhais hluas, nrog ntau dua 80 feem pua ntawm cov neeg siv e-luam yeeb hnub nyoog 12 txog 17 xyoo siv ib qho ntawm cov khoom no." Cov tuam txhab uas xav mus muag lawv cov khoom qab zib ENDS yuav tsum muaj pov thawj ntseeg tau tias cov txiaj ntsig zoo. Mitch Zeller, tus thawj coj ntawm FDA's Center for Tobacco Products tau hais tias qhov kev lav phib xaub yog nyob ntawm cov neeg thov los muab pov thawj tias kev muag khoom ntawm lawv cov khoom ua tau raws li kev cai lij choj ntawm "tsim nyog. tiv thaiv pej xeem kev noj qab haus huv".
FDA ceeb toom ntau dua 15 lab cov khoom
Lub hli dhau los, FDA ceeb toom cov tuam txhab nrog ntau dua 15 lab cov khoom lag luam kom tshem tawm cov khoom lag luam e-luam yeeb uas tsis tau tso cai los ntawm kev ua lag luam:
FDA hnub no tau tshaj tawm tsab ntawv ceeb toom rau ib lub tuam txhab muag cov khoom lag luam luam yeeb hauv FDA, suav nrog ntau cov kua qab e-kua, rau kev muag khoom tsis raug cai ntawm cov khoom siv hluav taws xob Nicotine Delivery System (ENDS) yam tsis muaj ntawv tso cai.Qhov kev txiav txim no qhia tau hais tias lub koom haum cog lus tsis tu ncua los xyuas kom meej tias cov khoom lag luam luam yeeb tau ua raws li txoj cai los tiv thaiv cov tub ntxhais hluas thiab kev noj qab haus huv zoo dua.
Cov ntawv ceeb toom yog tshwm sim los ntawm kev saib xyuas tsis tu ncua thiab kev saib xyuas hauv Internet rau kev ua txhaum cai ntawm kev haus luam yeeb thiab cov cai.FDA xav kom txhua tus neeg tsim khoom lag luam thiab cov khw muag khoom ntawm cov khoom lag luam luam yeeb kom paub tias peb tseem saib xyuas kev ua lag luam nyob ze thiab yuav tuav cov tuam txhab lav ris rau kev ua txhaum cai.
FDA yuav txuas ntxiv ua qhov tseem ceeb rau cov tuam txhab lag luam uas muag ENDS yam tsis muaj kev tso cai tsim nyog thiab tsis tau ua daim ntawv thov kev lag luam ua ntej nrog lub koom haum, tshwj xeeb yog cov uas yuav siv lossis tso cov khoom lag luam hluas. "
Hnub no, FOOD and Drug Administration tau xa tsab ntawv ceeb toom rau Visible Vapors LLC, lub tuam txhab hauv Pennsylvania uas ua thiab ua haujlwm lub vev xaib muag hluav taws xob nicotine Delivery System (ENDS) cov khoom,
suav nrog e-luam yeeb thiab e-kua, qhia rau lawv, Nws yog qhov txhaum cai muag cov khoom luam yeeb tshiab no yam tsis tau tso cai ua ntej, yog li lawv tsis tuaj yeem muag lossis faib hauv Tebchaws Meskas.Lub tuam txhab tsis tau xa ib daim ntawv thov ua ntej Kev Lag Luam Tobacco Product (PMTA) ua ntej lub Cuaj Hlis 9, 2020 hnub kawg.
Pib txij Lub Yim Hli 8, 2016, kev tshuaj xyuas ua ntej kev lag luam rau qee yam khoom luam yeeb uas suav tias yog tshiab, suav nrog e-luam yeeb thiab e-kua, yuav tsum xa mus rau FDA los ntawm lub Cuaj Hli 9, 2020, raws li lub tsev hais plaub txiav txim.
Tsab ntawv ceeb toom tau tshaj tawm hnub no hais txog cov khoom lag luam tshwj xeeb, suav nrog Visible Vapors Irish Potato 100mL thiab Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, Lub tuam txhab muaj ntau tshaj 15 lab cov khoom lag luam teev nrog FDA thiab yuav tsum xyuas kom meej tias tag nrho nws cov khoom ua raws. tsoom fwv cov kev cai, nrog rau cov kev cai saib xyuas ua ntej.
Raws li lub koom haum tswj hwm qhov tseem ceeb, tom qab lub Cuaj Hlis 9, 2020, FDA yuav ua qhov tseem ceeb rau kev tswj hwm cov khoom lag luam ENDS uas tseem tab tom ua lag luam thiab tsis tau txais daim ntawv thov khoom.
Nyob nruab nrab ntawm Lub Ib Hlis thiab Lub Rau Hli 2021, FDA tau xa 131 tsab ntawv ceeb toom rau cov tuam txhab muag lossis faib ntau dua 1,470,000 qhov tsis tau tso cai ENDS uas tsis xa daim ntawv thov ua ntej rau cov khoom lag luam los ntawm lub Cuaj Hlis 9 lub sijhawm kawg.
Cov tuam txhab uas tau txais tsab ntawv ceeb toom los ntawm FDA yuav tsum xa cov lus teb tsis pub dhau 15 hnub ua haujlwm tom qab tau txais tsab ntawv hais txog lub tuam txhab kev kho, suav nrog hnub ua txhaum cai raug txiav tawm thiab / lossis hnub uas cov khoom raug xa tawm.Lawv kuj xav kom cov tuam txhab txuas ntxiv ua raws li cov phiaj xwm yav tom ntej raws li Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj thiab Tshuaj pleev ib ce
Post lub sij hawm: Oct-15-2021
