Ngā Whakatūpato Hauora Hikareti
Nā te Ture Ārai Auahi me te Whakahaere Tupeka a te Whānau (TCA) i tuku mana hou ki te FDA hei whakahaere i te hanga, te hokohoko, me te tohatoha o ngā hua tupeka. I whakatikatikaina hoki e te TCA te Wāhanga 4 o te Ture Tapanga me te Pānui Hikareti ā-Motu (FCLAA), me te whakahau i te FDA kia whakaputa ture e hiahia ana kia whakaatuhia ngā whakairoiro tae e whakaatu ana i ngā pānga kino ki te hauora o te auahi hei hoa mō ngā tauākī whakatūpato tuhinga hou. Ka whakatikatikaina e te TCA te FCLAA kia hiahiatia iakete hikaretime te pānuitanga hei whakaatu i tētahi o ngā whakatūpato hou e hiahiatia ana.
I te marama o Poutū-te-rangi 2020, i whakaotihia e te FDA ngā "Whakatūpato e Hiahiatia ana mōNgā Kete Hikareti"me ngā Pānuitanga", e whakatū ana i ngā whakatūpato hauora hikareti hou e 11, kei roto ko ngā kōrero whakatūpato tuhinga me ngā whakairoiro tae, i roto i te ahua o ngā whakaahua whakaahua-tūturu e whakaatu ana i ngā hua kino ki te hauora o te momi hikareti. Ko ēnei whakatūpato hou e hiahiatia ana e whakaatu ana i ētahi o ngā mōrearea hauora iti ake te mōhiotia, engari he nui te kino.
Kua whakaputaina hoki e te FDA te "Whakatūpato e Hiahiatia ana mōNgā Kete Hikaretime ngā Pānui – Aratohu Whakatutuki i ngā Ture a ngā Hinonga Iti” hei āwhina i ngā pakihi iti ki te mārama me te whakatutuki i te ture whakamutunga.
Te Tūnga o nāianei o te Ture Whakamutunga
I te 7 o Tīhema, 2022, i whakaputa te Kōti Takiwā o Amerika mō te Takiwā Rawhiti o Texas i tētahi whakatau i roto i te keehi RJ Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., Nama 6:20-cv-00176, e whakakore ana i ngā "Whakatūpato e Hiahiatia ana mōNgā Kete Hikareti"me ngā Pānuitanga" te ture whakamutunga. I te 21 o Poutū-te-rangi, 2024, i whakaputa te Kōti Pīra o Amerika mō te Rohe Tuarima i tētahi whakaaro e whakakore ana i te Kōti Takiwā, ā, i whakatau ko te ture a te FDA he rite ki te Whakatikatika Tuatahi. I tukuna e te whakaaro te take ki te Kōti Takiwā hei whakaaro mō ngā kereme e toe ana a ngā kaiwhakapae. I tukuna e ngā kaiwhakapae he tono mō te whakaora wā poto mō ngā kereme i tukuna. I te 14 o Hānuere, 2025, i whakauru te Kōti Takiwā i tētahi aukati tuatahi, ā, i whakaroahia te rā whai mana o te ture tae noa ki te whakaurunga o te whakataunga whakamutunga i roto i te kereme.
Aratohu ki te Ahumahi
I te 12 o Hepetema, 2024, i whakaputa te FDA i ngā aratohu mō te ahumahi e whakaahua ana i te kaupapa here whakamana a te tari mō te ture whakamutunga. Heoi, i ngā wā tata nei, i aukati te Kōti Takiwā i te FDA kia kaua e whakamana i te ture, ā, i whakaroahia te rā whai mana o te ture tae noa ki te whakaurunga o te whakataunga whakamutunga i roto i te kereme.
Ngā Whakatūpato e Hiahiatia ana mōNgā Kete Hikaretime ngā Pānuitanga
Rahi me te wāhi – Me kapi te whakatūpato e hiahiatia ana i te iti rawa i te 50 ōrau o runga o ngā panera o mua me muri o te kete hikareti (arā, ngā taha, ngā mata rānei e rua nui rawa atu o te kete).
Mō ngā kātene hikareti, me whakanoho ngā whakatūpato e hiahiatia ana ki te taha maui o ngā panera o mua me muri o te kātene, ā, me whakauru atu ki te 50 ōrau o ēnei panera i te iti rawa i te taha maui. Me puta tika te whakatūpato e hiahiatia ana ki runga i te kete, ā, me mārama te kitea i raro i tētahi kirihou, i tētahi atu takai mārama rānei.
Te Aronga – Me whakanoho te whakatūpato e hiahiatia ana kia rite te aronga o te tuhinga o te whakatūpato me ngā mōhiohio kē atu i runga i taua panera o te kete.
Hei tauira, mēnā ko te papa o mua o tētahikete hikaretikei roto ngā mōhiohio, pēnei i te ingoa waitohu o te hikareti, mai i te maui ki te matau, me puta hoki te whakatūpato e hiahiatia ana, tae atu ki te tauākī whakatūpato tuhinga, mai i te maui ki te matau.
Whakaaturanga me te tohatoha matapōkere, ōrite hoki – Me whakaatu matapōkere ngā whakatūpato e 11 e hiahiatia ana mō ngā kete i ia wā 12-marama, i roto i te maha o ngā wā ōrite e taea ana i runga i ia waitohu o te hua, ā, me tohatoha matapōkere hoki ki ngā rohe katoa o te Hononga o Amerika e hokohokohia ana te hua, e ai ki tētahi mahere hikareti kua whakaaetia e te FDA.
Ngā whakatūpato kore e taea te tango, ngā whakatūpato tuturu rānei – Me tāia tonutia ngā whakatūpato e hiahiatia ana ki runga, me whakapiri tonu rānei kikete hikareti.
Hei tauira, kaua ēnei whakatūpato e tāia, e whakanohoia rānei ki runga i tētahi tapanga kua whakapirihia ki tētahi takai o waho mārama ka tangohia pea kia uru atu ai ki te hua i roto i te kete.
Pānui Hikareti（Ngā Kete Hikareti）
Rahi me te wāhi – Mō ngā pānuitanga tā me ētahi atu pānuitanga he wāhanga tirohanga (tae atu ki, hei tauira, ngā pānuitanga i runga i ngā tohu, ngā whakaaturanga hokohoko, ngā whārangi tukutuku Ipurangi, ngā whārangi tukutuku pāpāho pāpori, ngā papaaho matihiko, ngā tono pūkoro, me ngā reta īmēra), me puta tika te whakatūpato e hiahiatia ana ki runga i te pānuitanga. Hei tāpiri, me 20 ōrau o te horahanga o te pānuitanga te iti rawa o ngā whakatūpato e hiahiatia ana i roto i te whakatakotoranga me te wāhi e kitea nuitia ana i te tihi o ia pānuitanga i roto i te rohe tapahi, mēnā he mea kei reira.
Hurihuri – Me hurihuri ngā whakatūpato e 11 e hiahiatia ana i ia toru marama, i roto i te raupapa tauutuutu, i roto i ngā pānuitanga mō ia waitohu hikareti, e ai ki tētahi mahere hikareti kua whakaaetia e te FDA.
Ngā whakatūpato kore e taea te tango, me ngā whakatūpato tuturu rānei – Me tā tonu ngā whakatūpato e hiahiatia ana ki runga i tētahi pānuitanga hikareti, me whakapiri tūturu rānei ki tētahi pānuitanga hikareti.
Ngā Mahere Hikareti mō ngā Whakatūpato e Hiahiatia ana
Ko te Wāhanga 4 o te FCLAA, i whakatikatikaina e te TCA, me te ture whakamutunga e hiahia ana kia tukuna e ngā kaihanga, ngā kaituku, me ngā kaihokohoko hikareti he mahere mō te whakaaturanga matapōkere me te tohatoha ōrite o ngā whakatūpato e hiahiatia ana i runga i ngā kete hikareti me te hurihanga ā-hauwhā o ngā whakatūpato e hiahiatia ana i roto i ngā pānuitanga hikareti, me te whiwhi whakaaetanga a te FDA mō ā rātou mahere i mua i te urunga mai o ngā hua e hiahiatia ana kia mau i aua whakatūpato ki te mākete.
Kua whakaputaina e te FDA te "Tukunga o ngā Mahere mōNgā Kete Hikaretime ngā Pānui Hikareti (Kua Whakahoutia)” hei āwhina i te hunga e tuku ana i ngā mahere hikareti mōngā kete hikaretime ngā pānuitanga.
Te whakaritenga mō te tuku i ngā mahere hikareti mōngā kete hikaretime ngā pānuitanga, me ngā whakaritenga motuhake e pā ana ki te whakaaturanga matapōkere me te tohatoha ōrite o ngā whakatūpato e hiahiatia ana i runga i ngā takai hikareti me te hurihanga ā-hauwhā o ngā whakatūpato e hiahiatia ana i roto i ngā pānuitanga hikareti, kei te Wāhanga 4(c) o te FCLAA me te 21 CFR 1141.10.
Te wā tuku: 27-Pepuere-2025