Cov Kev Cai rau Lub Thawv Luam Yeeb thiab Cov Lus Ceeb Toom Txog Kev Noj Qab Haus Huv

Cov Lus Ceeb Toom Txog Kev Noj Qab Haus Huv ntawm Luam Yeeb

Txoj Cai Tswj Kev Haus Luam Yeeb thiab Kev Tswj Luam Yeeb rau Tsev Neeg (TCA) tau muab txoj cai tshiab tseem ceeb rau FDA los tswj kev tsim khoom, kev lag luam, thiab kev faib cov khoom haus luam yeeb. TCA kuj tau hloov kho Tshooj 4 ntawm Txoj Cai Tswj Kev Sau Npe thiab Kev Tshaj Tawm Luam Yeeb ntawm Tsoom Fwv Teb Chaws (FCLAA), qhia FDA kom tshaj tawm cov cai uas yuav tsum muaj cov duab xim uas qhia txog cov teeb meem tsis zoo rau kev noj qab haus huv ntawm kev haus luam yeeb los nrog cov lus ceeb toom tshiab. TCA hloov kho FCLAA kom xav tau txhuapob luam yeebthiab kev tshaj tawm kom muaj ib qho ntawm cov lus ceeb toom tshiab uas yuav tsum tau ua.

 Thaum Lub Peb Hlis Ntuj xyoo 2020, FDA tau ua tiav "Cov Lus Ceeb Toom Yuav Tsum Tau Ua RauCov Pob Khoom Luam Yeebthiab Kev Tshaj Tawm” txoj cai, tsim 11 cov lus ceeb toom tshiab txog kev noj qab haus huv ntawm cov luam yeeb, uas muaj cov lus ceeb toom sau ua ntawv nrog rau cov duab xim, ua cov duab zoo li tiag tiag, piav qhia txog cov teeb meem tsis zoo ntawm kev haus luam yeeb. Cov lus ceeb toom tshiab no piav qhia txog qee qhov kev pheej hmoo loj ntawm kev haus luam yeeb uas tsis tshua paub, tab sis muaj kev pheej hmoo loj rau kev noj qab haus huv ntawm kev haus luam yeeb.

 FDA kuj tau tshaj tawm "Cov Lus Ceeb Toom Yuav Tsum Tau Ua rauCov Pob Khoom Luam Yeebthiab Kev Tshaj Tawm - Phau Ntawv Qhia Txog Kev Ua Raws Cai Rau Cov Tuam Txhab Me” los pab cov lag luam me nkag siab thiab ua raws li txoj cai kawg.

Qhov Xwm Txheej Tam Sim No ntawm Txoj Cai Kawg

Thaum Lub Kaum Ob Hlis 7, 2022, Lub Tsev Hais Plaub Hauv Cheeb Tsam Tebchaws Meskas rau Sab Hnub Tuaj ntawm Texas tau tshaj tawm ib daim ntawv txiav txim hauv RJ Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, tshem tawm "Cov Lus Ceeb Toom Yuav Tsum Tau Ua rauCov Pob Khoom Luam Yeebthiab Kev Tshaj Tawm” txoj cai kawg. Thaum Lub Peb Hlis 21, 2024, Lub Tsev Hais Plaub Qib Siab ntawm Tebchaws Meskas rau Tsib Lub Rooj Sib Tham tau tshaj tawm ib qho kev xav thim rov qab Lub Tsev Hais Plaub Hauv Cheeb Tsam thiab xaus lus tias FDA txoj cai yog sib xws nrog Thawj Txoj Cai Hloov Kho. Lub tswv yim tau xa cov ntaub ntawv rov qab mus rau Lub Tsev Hais Plaub Hauv Cheeb Tsam kom txiav txim siab txog cov neeg foob cov lus thov uas tseem tshuav. Cov neeg foob tau xa daim ntawv thov kom pab txhawb nqa ib ntus rau cov lus thov uas raug xa rov qab. Thaum Lub Ib Hlis 14, 2025, Lub Tsev Hais Plaub Hauv Cheeb Tsam tau nkag mus rau hauv kev txwv tsis pub ua ntej thiab ncua hnub siv txoj cai kom txog thaum nkag mus rau qhov kev txiav txim zaum kawg hauv kev foob.

Kev Qhia rau Kev Lag Luam

Thaum lub Cuaj Hlis 12, 2024, FDA tau tshaj tawm cov lus qhia rau kev lag luam uas piav qhia txog txoj cai tswjfwm ntawm lub koom haum rau txoj cai kawg. Txawm li cas los xij, tsis ntev los no, Lub Tsev Hais Plaub Hauv Cheeb Tsam tau txwv tsis pub FDA siv txoj cai thiab ncua hnub siv txoj cai kom txog thaum nkag mus rau qhov kev txiav txim zaum kawg hauv kev foob.

 Cov Lus Ceeb Toom Yuav Tsum Muaj RauCov Pob Khoom Luam Yeebthiab Cov Kev Tshaj Tawm

Cov Pob Khoom Luam Yeeb

Qhov Loj thiab Qhov Chaw - Cov lus ceeb toom yuav tsum muaj tsawg kawg yog 50 feem pua ​​​​​​ntawm sab saum toj ntawm lub vaj huam sib luag pem hauv ntej thiab tom qab ntawm lub pob luam yeeb (piv txwv li, ob sab loj tshaj plaws lossis qhov chaw ntawm lub pob).

 Rau cov thawv luam yeeb, cov lus ceeb toom yuav tsum tau muab tso rau sab laug ntawm cov vaj huam sib luag pem hauv ntej thiab tom qab ntawm lub thawv thiab yuav tsum muaj tsawg kawg yog 50 feem pua ​​​​​​ntawm cov vaj huam sib luag no. Cov lus ceeb toom yuav tsum tshwm sim ncaj qha rau ntawm pob khoom thiab yuav tsum pom tseeb hauv qab cov cellophane lossis lwm yam khoom qhwv kom meej.

Kev Taw Qhia - Cov lus ceeb toom uas xav tau yuav tsum tau muab tso rau hauv qhov chaw kom cov ntawv nyeem ntawm cov lus ceeb toom uas xav tau thiab lwm cov ntaub ntawv ntawm lub vaj huam sib luag ntawm pob khoom muaj tib qho kev taw qhia.

 Piv txwv li, yog tias lub vaj huam sib luag pem hauv ntej ntawm ibpob luam yeebmuaj cov ntaub ntawv, xws li lub npe lag luam ntawm cov luam yeeb, nyob rau sab laug mus rau sab xis, cov lus ceeb toom uas xav tau, suav nrog cov lus ceeb toom sau, kuj yuav tsum tshwm sim nyob rau sab laug mus rau sab xis.

Kev tso saib thiab faib tawm yam tsis xaiv thiab sib npaug zos - Tag nrho 11 cov lus ceeb toom uas yuav tsum tau muab tso tawm yam tsis xaiv hauv txhua lub sijhawm 12 lub hlis, sib npaug zos ntau zaus li ntau tau ntawm txhua hom khoom thiab yuav tsum tau muab faib yam tsis xaiv hauv txhua thaj chaw ntawm Tebchaws Meskas uas cov khoom lag luam muag, raws li txoj kev npaj luam yeeb uas FDA pom zoo.

Cov lus ceeb toom uas tshem tsis tau lossis mus tas li - Cov lus ceeb toom uas yuav tsum tau muab luam tawm tsis tau lossis muab lo rau tas mus li rau ntawmpob luam yeeb.

 Piv txwv li, cov lus ceeb toom no yuav tsum tsis txhob muab luam tawm lossis muab tso rau ntawm daim ntawv lo uas muab lo rau ntawm daim ntawv qhwv sab nraud uas yuav raug tshem tawm kom nkag mus rau cov khoom hauv pob khoom.

Cov Kev Tshaj Tawm Luam Yeeb (Cov Pob Khoom Luam Yeeb)

Qhov Loj thiab Qhov Chaw - Rau cov ntawv tshaj tawm luam tawm thiab lwm cov ntawv tshaj tawm uas muaj cov khoom pom (xws li, piv txwv li, cov ntawv tshaj tawm ntawm cov paib, cov khoom muag, cov nplooj ntawv web hauv Is Taws Nem, cov nplooj ntawv social media, cov platform digital, cov ntawv thov mobile, thiab kev sib txuas lus email), cov lus ceeb toom yuav tsum tshwm sim ncaj qha rau ntawm kev tshaj tawm. Tsis tas li ntawd, cov lus ceeb toom yuav tsum muaj tsawg kawg yog 20 feem pua ​​​​​​ntawm thaj chaw ntawm kev tshaj tawm hauv hom ntawv pom tseeb thiab qhov chaw nyob rau sab saum toj ntawm txhua qhov kev tshaj tawm hauv thaj chaw txiav, yog tias muaj.

Kev Hloov Pauv - 11 cov lus ceeb toom uas yuav tsum tau hloov pauv txhua peb lub hlis, ua ntu zus, hauv kev tshaj tawm rau txhua hom luam yeeb, raws li txoj kev npaj luam yeeb uas FDA pom zoo.

Cov lus ceeb toom uas tshem tsis tau lossis nyob mus ib txhis - Cov lus ceeb toom uas yuav tsum tau muab luam tawm tsis tau lossis muab lo rau tas mus li rau ntawm daim ntawv tshaj tawm luam yeeb.

Cov Phiaj Xwm Luam Yeeb rau Cov Lus Ceeb Toom Yuav Tsum Tau Ua

Tshooj 4 ntawm FCLAA, raws li TCA tau hloov kho, thiab txoj cai kawg yuav tsum tau kom cov chaw tsim khoom, cov neeg faib khoom, thiab cov khw muag khoom luam yeeb xa ib txoj kev npaj rau kev tso saib thiab faib cov lus ceeb toom uas yuav tsum tau muaj rau ntawm cov pob luam yeeb thiab kev hloov pauv txhua peb lub hlis ntawm cov lus ceeb toom uas yuav tsum tau muaj hauv kev tshaj tawm luam yeeb, thiab kom tau txais kev pom zoo los ntawm FDA ntawm lawv cov phiaj xwm ua ntej cov khoom uas yuav tsum muaj cov lus ceeb toom no nkag mus rau hauv kev ua lag luam.

 FDA tau tshaj tawm "Kev Xa Cov Phiaj Xwm rauCov Pob Khoom Luam Yeebthiab Kev Tshaj Tawm Luam Yeeb (Kho Dua)” cov lus qhia los pab cov neeg xa cov phiaj xwm luam yeeb raucov pob luam yeebthiab kev tshaj tawm.

 Qhov yuav tsum tau xa cov phiaj xwm luam yeeb raucov pob luam yeebthiab cov ntawv tshaj tawm, thiab cov kev cai tshwj xeeb ntsig txog kev tso saib thiab faib cov lus ceeb toom uas xav tau ntawm cov ntawv ntim luam yeeb thiab kev hloov pauv txhua peb lub hlis ntawm cov lus ceeb toom uas xav tau hauv kev tshaj tawm luam yeeb, tshwm sim ntawm Tshooj 4 (c) ntawm FCLAA thiab 21 CFR 1141.10.