“Na ka FDA ke kuleana no ka hōʻoia ʻana e hoʻokomo ʻia nā huahana paka hou ma ke kaʻina loiloi hoʻoponopono kūpono e hoʻoholo ai inā kūpono lākou i nā kūlana olakino olakino o ke kānāwai ma mua o ka hiki ke kūʻai ʻia.Inā ʻaʻole i kūpono kahi huahana i ke kūlana kūikawā a laila hoʻopuka ka ʻoihana i kahi kauoha e hōʻole ana i ka noi kūʻai.ʻAʻole ʻae ʻia ke kūʻai aku i kahi huahana paka hou ma ʻAmelika Hui Pū ʻIa me ka loaʻa ʻole o ka mana kūʻai mai ka FDA.
ʻO kekahi o kā mākou mea nui e hōʻoia i ka mālama ʻia ʻana o nā mea hana no ke kūʻai ʻana i nā huahana paka i ʻae ʻole ʻia.Hōʻike ka hana o kēia lā e hoʻomaka ana mākou i ka hoʻokō ʻana i nā mea hana paka i loaʻa i kahi hana maikaʻi ʻole ma kā lākou noi, e like me ka Marketing Denial Order a i ʻole Refuse to File i ka hoʻolaha ʻana a hoʻomau i ke kūʻai ʻole ʻana i kēlā mau huahana ʻae ʻole, a me nā huahana i hāʻule ʻole ai nā mea hana. e waiho i ka palapala noi kuai.
ʻO kā mākou kuleana e hōʻoia i ka hoʻokō ʻana o nā mea hana paka i ke kānāwai no ka pale ʻana i ke olakino lehulehu a e hoʻomau mākou i nā ʻoihana no ka uhai ʻana i ke kānāwai.
ʻIke hou aku
● I kēia lā, ua hoʻopuka ka US Food and Drug Administration i nā leka hoʻomaopopo i nā hui 20 no ka hoʻomau ʻana i ke kūʻai hewa ʻole ʻana i nā huahana electronic nicotine delivery system (ENDS) i ke kumuhana o Marketing Denial Orders (MDOs).ʻO kēia nā leka ʻōlelo aʻo mua i hoʻopuka ʻia no nā huahana e pili ana i nā hoʻoholo MDO ma kā lākou noi huahana paka paka mua (PMTA).
● Ua hoʻopuka pū ka FDA i nā leka aʻo i kēia lā no ke kūʻai ʻole ʻana i nā huahana paka i kekahi hui i loaʻa nā manaʻo hoʻoholo Refuse to File (RTF) ma kā lākou PMTA, hoʻokahi hui i loaʻa nā manaʻo RTF a me MDO ma kā lākou PMTA, a me ʻeono mau hui ʻaʻole i waiho mai. nā noi premarket.
● I ka hui pū ʻana, ua helu kēia mau hui 28 i ka huina o nā huahana ʻoi aku ma mua o 600,000 me ka FDA.
● Mai ka lā 23 o Kepakemapa, ua hoʻopuka ka FDA i 323 mau MDO, ʻoi aku ma mua o 1,167,000 mau huahana ʻono ENDS.
● E hoʻomau ka FDA i ka hoʻokō mua ʻana i nā hui e kūʻai aku ana i nā huahana ENDS me ka ʻole o ka ʻae i koi ʻia–ʻo ia hoʻi kēlā mau huahana me ka hiki ke hoʻohana a hoʻomaka paha.
Ka manawa hoʻouna: Jan-10-2022