Izixwayiso Zezempilo zikagwayi
I-Family Smoking Prevention and Tobacco Control Act (TCA) inikeze i-FDA igunya elisha elibalulekile lokulawula ukukhiqizwa, ukumaketha, nokusatshalaliswa kwemikhiqizo kagwayi. I-TCA iphinde yachibiyela ISigaba 4 Somthetho Wokulebula Nokukhangisa We-Federal Cigarette (FCLAA), iqondise i-FDA ukuthi ikhiphe imithetho edinga izithombe ezinemibala ebonisa imiphumela yezempilo engemihle yokubhema ukuthi ihambisane nezitatimende zesexwayiso zombhalo omusha. I-TCA ichibiyela i-FCLAA ukuze idinge ngayinyeiphakethe likagwayikanye nesikhangiso esizofaka isexwayiso esisha esidingekayo.
NgoMashi 2020, i-FDA yaphothula “Izixwayiso Ezidingekayo zeAmaphakheji kagwayikanye Nomthetho Wokukhangisa”, osungula izexwayiso zezempilo zikagwayi ezintsha ezingu-11, ezihlanganisa izitatimende eziyisixwayiso ezingokombhalo ezihambisana nezithombe ezinemibala egqamile, ebonisa imiphumela emibi yempilo yokubhema ugwayi.
I-FDA iphinde ishicilele “Izixwayiso Ezidingekayo zeAmaphakheji kagwayikanye Nezikhangiso - Umhlahlandlela Wokuthobela Ibhizinisi Elincane” ukusiza amabhizinisi amancane aqonde futhi athobele umthetho wokugcina.
Isimo Samanje Somthetho Wokugcina
Ngomhla ka-Dec. 7, 2022, Inkantolo Yesifunda Yase-US Yesifunda Esisempumalanga Ye-Texas yakhipha umyalo e-RJ Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, eshiya “Izixwayiso Ezidingekayo ZeAmaphakheji kagwayikanye nesimiso Sokugcina Sezikhangiso”. Ngomhla zingama-21 kuNdasa, 2024, Inkantolo Yezikhalo Yase-US Yesifunda Sesihlanu yakhipha umbono ohoxisa iNkantolo Yesifunda futhi yaphetha ngokuthi isimiso se-FDA sihambisana Nesichibiyelo Sokuqala. Umbono wabuyisela icala eNkantolo Yesifunda ukuze kucutshungulwe izimangalo ezisele zabamangali. Ummangali wafaka isicelo sokukhulula ummangali ngoJanuwari. 14, 2025, iNkantolo Yesifunda yafaka umyalo wokuqala futhi yahlehlisa usuku lokuqalisa lomthetho kuze kube kufakwa isinqumo sokugcina ecaleni.
Isiqondiso Sezimboni
Ngomhla ziyi-12 Septhemba 2024, i-FDA yakhipha isiqondiso somkhakha esichaza inqubomgomo yokuphoqelela yesikhungo somthetho wokugcina. Kodwa-ke, muva nje, iNkantolo Yesifunda yayala i-FDA ukuthi isebenzise lo mthetho futhi yahlehlisa usuku lokuqalisa lomthetho kuze kube kufakwa isinqumo sokugcina ecaleni.
Izexwayiso ezidingekayo zeAmaphakheji kagwayikanye Nezikhangiso
Ubukhulu kanye nendawo - Isexwayiso esidingekayo kufanele sihlanganise okungenani amaphesenti angama-50 aphezulu amaphaneli angaphambili nangemuva ephakheji likagwayi (okungukuthi, izinhlangothi ezimbili ezinkulu noma izindawo ezingaphezulu zephakheji).
Emakhathoni kagwayi, izixwayiso ezidingekayo kufanele zibekwe ohlangothini lwesobunxele lwamaphaneli angaphambili nangemuva ebhokisi futhi kufanele ahlanganise okungenani amaphesenti angama-50 kwesokunxele ala maphaneli. Isexwayiso esidingekayo kufanele sivele ngqo ephaketheni futhi kufanele sibonakale ngokucacile ngaphansi kwanoma iyiphi i-cellophane noma okunye ukugoqa okucacile.
Ukuma - Isexwayiso esidingekayo kufanele sibekwe endaweni ukuze umbhalo wesexwayiso esidingekayo kanye nolunye ulwazi kulelo phaneli yephakeji kube nokuma ngakunye.
Isibonelo, uma iphaneli yangaphambili ye-aiphakethe likagwayiiqukethe ulwazi, njengegama lebhrendi likagwayi, ukusuka kwesokunxele ukuya kwesokudla, isixwayiso esidingekayo, okuhlanganisa isitatimende esiyisixwayiso sombhalo, kufanele futhi sivele ngomumo wesobunxele kuya kwesokudla.
Ukuboniswa nokusatshalaliswa okungahleliwe nokulinganayo - Zonke izixwayiso ezidingekayo ezingu-11 zamaphakheji kufanele ziboniswe ngokungahleliwe enkathini ngayinye yezinyanga ezingu-12, ngokulingana nenani lezikhathi ngangokunokwenzeka kumkhiqizo ngamunye womkhiqizo futhi kufanele zisatshalaliswe ngokungahleliwe kuzo zonke izindawo zase-United States lapho umkhiqizo ukhangiswa khona, ngokuvumelana nohlelo lukagwayi olugunyazwe i-FDA.
Izixwayiso ezingenakususwa noma ezingunaphakade - Izixwayiso ezidingekayo kufanele ziphrintwe ngokungenakucimeka noma zinamathiselwe unomphelaiphakethe likagwayi.
Isibonelo, lezi zexwayiso ezidingekayo akufanele ziphrintwe noma zibekwe kulebula enamathiselwe kwisonga sangaphandle esicacile esingase sisuswe ukuze kufinyelelwe kumkhiqizo ngaphakathi kwephakheji.
Izikhangiso zikagwayi.Amaphakheji kagwayi）
Ubukhulu kanye nendawo - Ngezikhangiso eziphrintiwe kanye nezinye izikhangiso ezinengxenye ebonakalayo (okubandakanya, isibonelo, izikhangiso zezimpawu, izibonisi zezitolo, amakhasi ewebhu e-inthanethi, amakhasi ewebhu enkundla yezokuxhumana, izinkundla zedijithali, izinhlelo zokusebenza zeselula, kanye nezincwadi ze-imeyili), isixwayiso esidingekayo kufanele sivele ngqo esikhangisweni. Ukwengeza, izexwayiso ezidingekayo kufanele zihlanganise okungenani amaphesenti angu-20 wendawo yesikhangiso ngefomethi esobala nevelele kanye nendawo phezulu kwesikhangisi ngasinye ngaphakathi kwendawo yokunquma, uma ikhona.
Ukuzungezisa - Izixwayiso ezidingekayo eziyi-11 kufanele zishintshwe njalo ngekota, ngokulandelana okushintshanayo, ezikhangisweni zohlobo ngalunye lukagwayi, ngokuhambisana nohlelo lukagwayi olugunyazwe yi-FDA.
Izexwayiso ezingasuseki noma ezihlala njalo - Izexwayiso ezidingekayo kufanele ziphrintwe ngokungenakucimeka noma zinamathiselwe unomphela esikhangisweni sikagwayi.
Izinhlelo zikagwayi zezixwayiso ezidingekayo
Isigaba sesi-4 se-FCLAA, njengoba uchitshiyelwe yi-TCA, kanye nomthetho wokugcina udinga ukuthi abakhiqizi, abasabalalisi, nabathengisi bakagwayi balethe uhlelo lokuboniswa okungahleliwe nokulinganayo kanye nokusatshalaliswa kwezixwayiso ezidingekayo kumaphakheji kagwayi kanye nokuzungeziswa kwekota kwezixwayiso ezidingekayo ezikhangisweni eziyisixwayiso zikagwayi, futhi bathole imvume ye-FDA yezinhlelo zabo ngaphambi kokuba imikhiqizo ifakwe emakethe.
I-FDA ikhiphe “Ukuhanjiswa Kwezinhlelo zeAmaphakheji kagwayikanye nezikhangisi zikagwayi (ezibuyekeziwe)” ukusiza labo abaletha izinhlelo zikagwayiamaphakheji kagwayikanye nezikhangiso.
Isidingo sokulethwa kwezinhlelo zikagwayi zeamaphakheji kagwayikanye nezikhangiso, kanye nezimfuneko ezithile ezihlobene nokuboniswa okungahleliwe nokulinganayo kanye nokusatshalaliswa kwezixwayiso ezidingekayo ekufakweni kukagwayi kanye nokuzungezisa ngekota kwezixwayiso ezidingekayo ekukhangiseni kukagwayi, zivela kuSigaba 4(c) se-FCLAA kanye 21 CFR 1141.10.
Isikhathi sokuthumela: Feb-27-2025