E pili ana i ka FDA
"Ua hāʻawi ka ʻaha kūkā i ka FDA e hoʻoponopono i nā huahana paka ma o ka nānā ʻana i ka ʻepekema e pale aku i ka lehulehu mai nā hopena ʻino o ka hoʻohana ʻana i ka paka," wahi a ke Komisina FDA ʻo Janet Woodcock."ʻO ka hōʻoia ʻana i ka loiloi ʻia ʻana o nā huahana paka hou e FDA he ʻāpana koʻikoʻi ia o kā mākou pahuhopu e hōʻemi i ka maʻi pili i ka paka a me ka make. ʻO ka poʻe ʻōpio ke kumu nui i ka hoʻoholo ʻana i nā huahana hiki ke kūʻai ʻia."
Ke hōʻailona nei kēia hana i ka holomua nui i ka loaʻa ʻana o ka helu i loaʻa ʻole ma mua o ka lā 9 Kepakemapa 2020 i kauoha ʻia e ka ʻaha no ka waiho ʻana i nā noi premarket i manaʻo ʻia he mau huahana paka hou, a me ka manawa kūpono e hoʻoponopono ai i ka hoʻohana ʻana i nā ʻōpio.
Ua loaʻa i ka FDA nā noi mai nā hui ʻoi aku ma mua o 500 e uhi ana ma mua o 6.5 miliona mau huahana paka.ʻOiai ua hoʻopuka ka ʻoihana i nā hana ʻino ʻē aʻe ma kekahi mau noi, ʻo kēia ka pūʻulu mua o Mdos ka FDA i hoʻopuka no nā noi e kū ana i ka ʻāpana loiloi ʻepekema nui o ka loiloi premarket.Ua kūpaʻa ka ʻoihana i ka hoʻololi ʻana i ka mākeke o kēia manawa i kahi mākeke kahi e hōʻike ʻia ai nā huahana ENDS a pau i kūʻai ʻia e "kūpono i ke olakino lehulehu".
Ma ʻAukake 27, ua hoʻolaha ka FDA ua hōʻole ʻo ia i 55,000 premarket tobacco applications (PMTAS) mai ʻekolu mau mea hana e-cigarette liʻiliʻi no ka mea ʻaʻole lākou i hāʻawi i nā hōʻike e pale ana lākou i ke olakino lehulehu.
Ua loaʻa i ka FDA ~ 6.5 miliona mau noi PMTA no nā e-cigarettes ma ka lā palena ʻo Kepakemapa 9, waiho ʻia ~ 2 miliona mau noi i hoʻolaha ʻole ʻia, me ka ʻole o ~ 4.5 miliona mau noi (JD Nova Group LLC) i hoʻolaha mua ʻia ʻaʻole i hoʻokō i nā koi.Me nā noi 55,000 i hōʻole ʻia i kēia manawa, ʻoi aku ka liʻiliʻi ma mua o 1.95 miliona mau mea i hoʻolaha ʻole ʻia.ʻO ka mea hou aʻe, ʻo nā hana a ka FDA e hōʻike ana ʻaʻole ia e ʻae i kekahi ʻaila e-cigarette bottled i ʻono ʻē aʻe ma mua o ka paka.ʻElua pule ma mua o ka pau ʻana o ka manawa aloha i ka lā 9 Kepakemapa 2021, hiki ke manaʻo ʻia ʻaneʻane e hōʻole ʻia nā PMTAS i koe.
I kēia lā, ua hoʻopuka ka US Food and Drug Administration i nā kauoha hōʻole kūʻai mua (Mdos) no nā huahana uila Nicotine Delivery System (ENDS) ma hope o ka hoʻoholo ʻana i nā noi mai ʻekolu mau mea noi no kahi o 55,000 flavored ENDS huahana nele i ka hōʻike kūpono o ka pono no ka poʻe puhi paka.Ua lawa ka lanakila ʻana i ka hoʻoweliweli olakino lehulehu e nā pae i kākau ʻia a weliweli o ka hoʻohana ʻana o nā ʻōpio i ia mau huahana.ʻO JD Nova Group LLC, Great American Vapes a me Vapor Salon ka ENDS ʻole paka, ʻo ia hoʻi ʻo Apple Crumble, Kauka Cola a me Cinnamon Toast Cereal.
Pono nā huahana ENDS ʻono i ka hōʻoia paʻa
ʻAʻole hiki ke hoʻolauna ʻia a hāʻawi ʻia paha nā huahana i koi ʻia no ka noi PRE-market no MDO i mea e hoʻolauna ai i ke kālepa waena.Inā aia ka huahana ma ka mākeke, pono e hoʻoneʻe ʻia mai ka mākeke a i ʻole e hoʻokō ʻia.ʻO ka MDO i hoʻolaha ʻia i kēia lā ʻaʻole i komo nā huahana ENDS a pau i waiho ʻia e ka hui;ke noonooia nei na noi no ke koena.Ua hōʻike mua ka FDA i kekahi o nā hui, ʻo JD Nova Group LLC, ʻaʻole i hoʻokō kāna noi huahana paka i mua o ka mākeke e pili ana i kāna mau huahana ma kahi o 4.5 miliona i nā koi noi no kahi huahana paka hou e ʻimi nei i ka mana kūʻai.
"He mea kaulana loa nā huahana ENDS i nā ʻōpio, me ka ʻoi aku o ka 80 pakeneka o nā mea hoʻohana e-cigarette mai 12 a 17 makahiki e hoʻohana ana i kekahi o kēia mau huahana. ʻO kā lākou huahana no nā mea puhi paka makua ma mua o nā pilikia nui i ʻike ʻia i ka poʻe ʻōpio," wahi a Mitch Zeller, ka luna o ka FDA's Center for Tobacco Products. ka palekana o ke olakino lehulehu". Inā lawa ʻole a lawa ʻole nā hōʻike, manaʻo ka FDA e hoʻopuka i kahi kauoha hōʻole kūʻai aku e koi ana i ka huahana e wehe ʻia mai ka mākeke a i ʻole ka wehe ʻana mai ka mākeke.
Hoʻomaopopo ka FDA ma mua o 15 miliona mau huahana
I ka hopena o ka mahina i hala aku nei, ua ʻōlelo ka FDA i nā hui me nā huahana he 15 miliona e wehe i nā huahana e-cigarette ʻae ʻole mai ka mākeke:
Ua hoʻopuka ka FDA i kēia lā i kahi leka hoʻomaopopo i kahi hui e kūʻai aku ana i nā huahana paka i helu ʻia e FDA, me ka nui o nā e-liquid ʻono, no ke kūʻai pono ʻole ʻana i nā huahana uila Nicotine Delivery System (ENDS) me ka laikini ʻole.Hōʻike kēia hana i ka hoʻokō mau ʻana o ka ʻoihana e hōʻoia i nā huahana paka i kūʻai ʻia e like me ke kānāwai no ka pale maikaʻi ʻana i ka ʻōpio a me ke olakino lehulehu.
ʻO nā leka hoʻolaha ka hopena o ka nānā mau ʻana a me ka nānā ʻana i ka Pūnaewele no ka uhaki ʻana i nā kānāwai paka a me nā lula.Makemake ʻo FDA i nā mea hana a me nā mea kūʻai aku o nā huahana paka e ʻike e hoʻomau mākou i ka nānā pono ʻana i ka mākeke a mālama i nā ʻoihana i ke kuleana no nā hewa.
E hoʻomau ka FDA i ka hoʻonohonoho mua ʻana i nā ʻoihana e kūʻai aku ana i ka ENDS me ka ʻole o ka ʻae ʻia a ʻaʻole i waiho i kahi noi premarket me ka ʻoihana, ʻoi aku ka poʻe e hoʻohana a hoʻomaka paha i nā huahana ʻōpio. "
I kēia lā, ua hoʻouna ka FOOD and Drug Administration i kahi leka hoʻomaopopo iā Visible Vapors LLC, kahi hui i hoʻokumu ʻia ma Pennsylvania e hana a hana i kahi pūnaewele e kūʻai aku ana i nā huahana uila nicotine Delivery System (ENDS).
me ka e-cigarettes a me ka e-liquids, e hai aku ana ia lakou, He mea pono ole ke kuai aku i keia mau mea paka hou me ka ae ole ia mamua o ke kuai ana, no laila, aole hiki ke kuai a mahele ia ma Amerika Huipuia.ʻAʻole i hāʻawi ka hui i kahi noi premarket Tobacco Product (PMTA) e ka lā 9 Kepakemapa 2020.
E hoʻomaka ana i ka lā 8 o ʻAukake, 2016, pono e waiho ʻia i ka FDA ma mua o Sepatemaba 9, 2020 nā noi loiloi mua no kekahi mau huahana paka i manaʻo ʻia he mea hou, me ka e-cigarettes a me ka e-liquid, e like me ke kauoha a ka ʻaha.
ʻO ka leka hoʻolaha i hoʻopuka ʻia i kēia lā i hōʻike ʻia i nā huahana kikoʻī, me Visible Vapors Irish Potato 100mL a me Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, Ua ʻoi aku ka ʻoihana ma mua o 15 miliona mau huahana i helu ʻia me ka FDA a pono e hōʻoia i nā huahana a pau e hoʻokō me. nā hoʻoponopono federal, me nā koi loiloi premarket.
E like me nā mea nui o ka hoʻokō ʻana o ke keʻena, ma hope o Kepakemapa 9, 2020, e hoʻomaka mua ka FDA i ka hoʻokō ʻana i nā huahana ENDS e hoʻomau ʻia ana ke kūʻai ʻia a ʻaʻole i loaʻa kahi noi huahana.
Ma waena o Ianuali a me Iune 2021, ua hoʻouna ka FDA i nā leka ʻōlelo aʻo 131 i nā hui e kūʻai aku a hāʻawi aku paha ma mua o 1,470,000 ENDS ʻae ʻole i hoʻouna ʻole i nā noi premarket no kēia mau huahana ma ka lā palena ʻo Kepakemapa 9.
Pono nā hui i loaʻa i ka leka hoʻomaopopo mai ka FDA mai i ka pane i kākau ʻia i loko o 15 mau lā ʻoihana ma hope o ka loaʻa ʻana o ka leka e hōʻike ana i ka hana hoʻoponopono a ka hui, me ka lā i hoʻopau ʻia ai ka uhaki ʻana a/a i ka lā i puʻunaue ʻia ai ka huahana.Pono lākou e hoʻomau i nā hui e hoʻokō i nā hoʻolālā e hiki mai ana ma lalo o ke Federal Food, Drug and Cosmetic Act
Ka manawa hoʻouna: ʻOkakopa-15-2021
