Suav E-luam yeeb Hom SMOK Appeals US FDA Kev Lag Luam Tsis Pom Zoo

Suav e-luam yeeb hom SMOK thov rau US FDA kev lag luam tsis kam xaj

Thaum Lub Ib Hlis Ntuj Tim 18, SMOK lub tuam txhab tau tshaj tawm tias nws tau thov tawm tsam US FDA qhov kev lees paub kev lag luam rau nws lub npe SMOK thiab tau xa mus rau US Lub Tsev Hais Plaub Txiav Txim Siab rau Fifth Circuit.

Thaum Lub Ib Hlis 18, Shenzhen Avipus Technology Co., Ltd. (tom qab no hu ua "Avipus Technology"), lub tuam txhab tseem ceeb ntawm SMOK hom, tshaj tawm tias nws tau tsis lees paub US FDA qhov kev lag luam ntawm nws SMOK hom qhib kaw lus e-luam yeeb cov khoom siv. thiab lwm yam khoom siv hloov pauv. Ib qho kev thov rov hais dua ntawm qhov kev txiav txim raug xa mus rau Tebchaws Meskas Lub Tsev Hais Plaub Txiav Txim Siab rau Fifth Circuit.

Yav dhau los, thaum Lub Ib Hlis 16, US FDA tau tshaj tawm xov xwm tshaj tawm tias lub chaw haujlwm tau tshaj tawm kev lag luam tsis lees paub rau kev ua lag luam ua ntej kev lag luam luam yeeb daim ntawv thov rau qhib cov khoom SMOK, suav nrog 22 cov khoom, vim tias cov ntawv thov no "ua tsis tiav cov ntaub ntawv txaus. " txhawm rau txheeb xyuas cov khoom xa tuaj, khoom ruaj khov, thiab kev tsim txom cov khoom. "

Avipex Technologies tawm tsam cov lus pom zoo no los ntawm FDA. Lub tuam txhab tau nqis peev ntau dua $ 30 lab hauv daim ntawv thov PMTA, tsim tag nrho ntau dua 600, 000 nplooj ntawv ntawm cov ntaub ntawv, thiab koom tes nrog lub ntiaj teb cov chaw soj ntsuam ua haujlwm los ua cov kev tshawb fawb muaj txiaj ntsig zoo thiab muaj txiaj ntsig zoo. Kev sim tshuaj aerosol rau cov khoom siv phom sij, hauv vitro toxicology kuaj thiab tshuaj xyuas tshuaj toxicology, nrawm thiab 24-hli cia thiab kuaj kev ruaj ntseg, thiab kev tshawb fawb soj ntsuam cov tshuaj pharmacokinetic nruj.

Ivypus kuj tau sau tseg tias qhov kev tsis lees paub kev lag luam uas tau hais hauv FDA tshaj tawm tau ua yuam kev hauv kev piav qhia txog qib kev xav tau ntawm cov tub ntxhais hluas siv cov khoom SMOK, raws li FDA tau thov tias 2023 National Youth Tobacco Survey tau qhia tias "11.3% ntawm cov tub ntxhais kawm theem nrab thiab theem siab. tshaj tawm tias yav dhau los 30 Siv SMOK cov khoom txhua hnub". Qhov tseeb, New York Times tau pom tias tsuas yog 7.7% ntawm cov tub ntxhais kawm theem siab thiab cov tub ntxhais kawm theem nrab tau tshaj tawm siv cov khoom lag luam nicotine e-luam yeeb rau ntau tshaj 30 hnub, thiab ntawm cov neeg siv, tsuas yog 11.3% qhia siv cov khoom SMOK.
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