I-JWEI Imemezela Ukuthunyelwa Kwesicelo Somkhiqizo Kagwayi Osemakethe Ngaphambi Kwemakethe (i-PMTA) Yomkhiqizo Wenkundla Yobuchwepheshe Omusha ku-US Food and Drug Administration Icela Isigunyazo Sokumaketha.

ISHENZHEN, China, July 21, 2022 - JWEI, umholi womhlaba wonke embonini kagwayi we-elekthronikhi, umemezela namuhla ukuthi bathumele ngempumelelo Isicelo Sogwayi Sangaphambi Kwemakethe ku-US Food and Drug Administration ukuze bathole idivayisi edalwe ngobuchwepheshe babo obusha obusha, obugxile ekuphepheni, ekunciphiseni ukulimala nokuklanywa. ukunqanda ukusetshenziswa kwezingane.

Njengomunye wabakhiqizi bemishini abahamba phambili emhlabeni nabasunguli bemikhiqizo kagwayi kanye ne-vaping, enamalungelo obunikazi anikiwe angaphezu kuka-3,600 kanye nezitifiketi zokukhiqiza nezitifiketi zekhwalithi ezaziwayo emhlabeni wonke (GMP, HACCP, ISO9001, ISO13485, EHS, kanye ne-ERP), i-JWEI izibophezele. ekufakeni isandla ekuthuthukisweni kwezempilo yomphakathi ngezinto ezintsha eziphusile nezinesibopho.

Ukubhema ugwayi kungenye yezinto ezisongela kakhulu impilo yomphakathi, kubulala abantu abangaphezu kwezigidi ezingu-7 emhlabeni wonke unyaka nonyaka. ¹. Cishe oyedwa kwabahlanu abafayo e-US kubangelwa ukubhema ugwayi minyaka yonke ². Uhide lwezifo ezihlobene nogwayi lude. Ngokudabukisayo, iningi lokufa nokugula kuyagwemeka.

Ugwayi uyalutha, ngokuyinhloko ngenxa yokuba khona kwe-nicotine, nakuba i-nicotine ngokwayo ingeyona imbangela eqondile yezifo eziningi ezihlobene nokubhema. ³. Abaningi ababhemayo abazama ukuyeka, kungaba ngokwabo noma ngosizo lwezinhlelo zokuyeka, bayehluleka emzamweni wabo. ^4 5 6.

Kukhona ukuqhubeka kwezingozi emikhiqizweni eletha i-nicotine, kusukela emikhiqizweni evuthayo eyingozi kakhulu (isb. ugwayi) kuya emikhiqizweni ye-nicotine yemithi eyingozi njengamanje efana nokwelashwa esikhundleni kwe-nicotine (NRT). Eminyakeni yamuva nje, ukunakwa sekuphendukele ekubeni nokwenzeka kokukhuthaza labo abangakwazi noma abangazimisele ukuyeka ukuthi banciphise ukusetshenziswa kukagwayi noma bashintshele kwezinye izinto eziyingozi kangako njengogwayi we-elekthronikhi njengomgomo ongase ube umphumela. ^6 7.

Kudinga indlela ebanzi, enezici eziningi kanye nemizamo yokubhekana nenkinga yokubhema ugwayi evela kubalawuli, abakhiqizi, osomabhizinisi, abacwaningi abasezikhungweni zemfundo ephakeme noma ezigabeni ezizimele, amaqembu okumela, nabasabalalisi kuyilapho kungadali olunye ubhubhane olusha entsheni nakubantu abasengozini.

Okokuqala, i-JWEI ithuthukise isethi yezimiso ezizoqondisa kuzo zonke izinyathelo zokuthuthukiswa komkhiqizo omusha, okuholwa izifundo zokuphepha nokusebenza ngempumelelo ngasekuqaleni kuka-2019. Ifilosofi yokuklama iyisisekelo kanye nezinsimbi eziqondisayo zokuklama, ukukhiqiza, ukuqinisekisa, ukuqinisekisa, nokuthuthukisa ngokuqhubekayo. imikhiqizo emisha, enesibopho, ethembekile, kanye nekhwalithi ephezulu. Ifilosofi yokuklama yasungulwa ngokucacile ekuqaleni kokuthuthukiswa kwenkundla yomkhiqizo omusha: Ukuguqula inselele yobhubhane lokubhema ibe ngcono amathuba ezempilo omphakathi ngezinto ezintsha eziphusile nezinesibopho.

Okwesibili, i-JWEI yakha ithimba elizinikele lezinhlaka eziningi okuhlanganisa osokhemisi be-aerosol, ososayensi bezinto ezibonakalayo, ongoti be-toxicologists, izazi zezifo eziwumshayabhuqe, odokotela, ososayensi bokuziphatha, kanye nabanye ochwepheshe bezihloko ukuze basebenzise ubuhlakani nokuqamba izinto ezintsha ukuze kufezeke ukuthuthukiswa komkhiqizo okunenjongo nokuphumelelayo.

Okwesithathu, i-JWEI ibambe izinga eliphezulu kusukela ekuqaleni kokuthuthukiswa kwenkundla yomkhiqizo omusha nakuyo yonke inqubo. Balethe ochwepheshe besizinda, okuhlanganisa onjiniyela bezinto eziphilayo kanye nochwepheshe bezokwelapha nokulawula abanolwazi olunzulu lwamashumi eminyaka kumishini yezokwelapha ye-Class III. Babeke phambili ukuphepha ngokuncishiswa kokulimala okukhulu kubasebenzisi kanye nemikhawulo yokufinyelela esekelwe kudivayisi ukuze kunqandwe ukuqalwa kwentsha.

Okwesine, i-JWEI ishumeke umhlahlandlela ophelele we-PMTA eqoqweni lemibandela ehambisanayo yokuthuthukiswa komkhiqizo nezinjongo zocwaningo. Ukuhlolwa okuphelele nokuhlelekile kanye nezifundo zenziwa kuwo wonke amazwekazi amathathu (Asia, Europe, Futhi i-America esenyakatho) enamalebhu amaningi ezinkampani zangaphandle aqinisekisiwe nabaphenyi abayinhloko abahlonishwayo nabacwaningi abavela embonini nasezifundweni, okuhlanganisa ukuhlolwa kwe-aerosol, ukuhlola ukuzinza, ukuhlolwa kwe-E&L, kwesibeletho ukuhlolwa kwe-toxicology, izifundo ze-biomarker, vivo i-pharmacokinetics, izifundo zomtholampilo, ukubonwa komkhiqizo kanye nezifundo zokuziphatha, ucwaningo lwezici zomuntu, ukuhlolwa kwezempilo komuntu ngamunye, izifundo zangempela zokusetshenziswa, imodeli yezempilo yabantu, kanye nokuhlola umthelela wendawo. Inqubo yokusebenzisana ngesandla ngesandla phakathi kokuthuthukiswa kwenkundla yomkhiqizo omusha kanye nokusebenzisa amamojula ocwaningo e-PMTA iveze imiphumela encomekayo ngokuyimpumelelo nangempumelelo. Isibonelo, umkhiqizo omusha uboniswe unciphisa>99.9% izakhi eziyingozi nezingase zibe yingozi (HPHC) uma kuqhathaniswa nogwayi ovuthayo. Lokhu kusebenza kahle kokudluliselwa kwe-nicotine kunganika amandla amandla okusetshenziswa kwe-nicotine okuphansi kakhulu ukuze kuhlangatshezwane nezidingo zabasebenzisi zokwehla, izici ezintsha nezisebenzayo zokuvimba ezidikibalisa kakhulu abangasebenzisi, kanye nekhono lokusekela iswishi njengomthombo oyinhloko we-nicotine ekusetshenzisweni kwangempela. phakathi kwabasebenzisi.

Okokugcina, ithimba eligqugquzelwa yimishini kuwo wonke amazwekazi amathathu (Asia, Europe, Futhi i-America esenyakatho) wasebenza ngokuzikhandla kulo msebenzi ubusuku nemini.

Ukuqala komkhiqizo olinganiselwe e-UK uthole ukuqashelwa okumangalisayo kubasebenzisi nozakwethu bezentengiso ngemva kokusetshenziswa kwangempela kwezinyanga ezimbalwa. Izici zekhwalithi ephezulu neziqanjiwe zithinta kahle abasebenzisi. Idemographics yokusetshenziswa kwangempela kokusatshalaliswa kweminyaka yobudala iphinde yabonisa ukuthi iningi labasebenzisi bangabasebenzisi bomkhiqizo we-nicotine asebedlule kakhulu. Osemncane ubudala. Ingqikithi yobufakazi yakha isisekelo esiqinile esibonisa umkhiqizo omusha futhi imikhiqizo yawo yesikhulumi inamandla amakhulu okusebenzisa umthelela omkhulu ku-APPH (efanele ukuvikela impilo yomphakathi).

Imibhalo engaphezu kuka-1,500, amakhulu emibiko yocwaningo, kanye namashumi ezinkulungwane zamakhasi ekuhanjisweni kokugcina kwe-PMTA kuhanjiswe ku-FDA. Isicelo manje sizobuyekezwa yi-FDA ngaphambi kokuthi i-ejensi inqume ukuthi yamukele isicelo sokufakwa kusiphi isigaba lapho izobe ibuyekezwa khona okokuqala ngokwesayensi ukuze kuqinisekiswe ukuthi isicelo siqukethe zonke izinto ezidingekayo ukuze kuvunyelwe ukubuyekezwa okuqinile yi-FDA. .

“I-JWEI ibingumholi kule mboni kusukela ekuqaleni futhi lesi sigameko esiyingqopha-mlando siphinda sigcizelela ukuzibophezela kwethu embonini nempilo yomphakathi: ukuqinisekisa ukuthi amakhasimende ethu amadala ayaqhubeka nokufinyelela kwezinye izindlela ezingezona eziyingozi emikhiqizweni kagwayi wendabuko, kuyilapho sibeka indinganiso entsha evimbela ukufinyelela kwentsha engaphansi. .” kusho Jason Yao, I-VP ye-JWEI Group.

References:

1. UBANI. Ugwayi,https://www.who.int/news-room/fact-sheets/detail/tobacco#:~:text=Key%20facts,exposed%20to%20second%2Dhand%20smoke.> (2022).
2. I-CDC. Ukubhema nokusebenzisa Ugwayi,https://www.cdc.gov/tobacco/data_statistics/fact_sheets/economics/econ_facts/index.htm> (2022).
3. Apelberg, BJ et al. Imiphumela Engaba Khona Yezempilo Yomphakathi Yokunciphisa Amazinga E-Nicotine Kugwayi I-the united states. N Engl J Med 378, 1725-1733, doi:10.1056/NEJMsr1714617 (2018).
4. I-Giovino, GA Epidemiology yokusetshenziswa kukagwayi ku I-the united states. oncogene 21, 7326-7340, doi:10.1038/sj.onc.1205808 (2002).
5. Messer, K. et al. Umphumela we-California Tobacco Control Programme kubantu abadala ababhemayo: (1) Ukuyeka ukubhema. Ukulawulwa Kokubhema 16, 85-90, doi:10.1136/tc.2006.016873 (2007).
6. U-Yong, HH, Borland, R., Hyland, A. & Siahpush, M. Umzamo wokuyeka ongaphumelelanga phakathi kwababhemayo abavamile uthinta kanjani ugwayi wabo? Okutholwe kuNhlolovo Yamazwe Ngamazwe Ane-Four-Tobacco Control Survey (ITC-4). nicotine I-Tob Res 10, 897-905, doi:10.1080/14622200802023841 (2008).
7. Smith, TT et al. Ukuthi ukuphusha noma ukudonsa? Ukunciphisa i-Nicotine nezinye izindlela ezingashiswanga - Amasu amabili okunciphisa ukubhema kanye nokwenza ngcono impilo yomphakathi. Edlule iMedi 117, 8-14, doi:10.1016/j.ypmed.2018.03.021 (2018).

IMINININGWANE: Fany Guo, [i-imeyili ivikelwe]

UMTHOMBO I-Shenzhen JWEI Electronics Co., LTD.

About the Author: injabulo