Ibisabwa mu gasanduku k'itabi n'ubuhamya ku buzima

Imiburo ku buzima bw'itabi

Itegeko ryo gukumira no kurwanya itabi mu miryango (TCA) ryahaye FDA ububasha bushya bwo kugenzura ikorwa, ubucuruzi, n'ikwirakwizwa ry'ibikomoka ku itabi. TCA yanavuguruye Ingingo ya 4 y'Itegeko rya Leta Zunze Ubumwe za Amerika ryo gutanga ibimenyetso no kwamamaza itabi (FCLAA), ritegeka FDA gutanga amabwiriza asaba ibishushanyo mbonera by'amabara bigaragaza ingaruka mbi ku buzima zo kunywa itabi kugira ngo biherekeze n'inyandiko nshya z'umuburo. TCA ivuguruye FCLAA kugira ngo isaba buri weseipaki y'itabino kwamamaza kugira ngo bibe bifite imwe mu miburo mishya isabwa.

 Muri Werurwe 2020, FDA yarangije "Imiburo Ikenewe kuriPake z'itabin'Amatangazo”, ashyiraho amabwiriza 11 mashya yo kubuza itabi ku buzima, agizwe n'inyandiko zikubiyemo imburizi ziherekejwe n'amabara, mu buryo bw'amashusho ahuye, agaragaza ingaruka mbi zo kunywa itabi ku buzima. Iyi miburo mishya isabwa igaragaza zimwe mu ngaruka zitazwi cyane ariko zikomeye zo kunywa itabi ku buzima.

 FDA yanashyize ahagaragara "Imiburo Ikenewe kuriPake z'itabin'Amatangazo – Inyoborabiganiro yo Kuyubahiriza Amategeko y'Ibigo Bito” kugira ngo ifashe ubucuruzi buto gusobanukirwa no kubahiriza itegeko rya nyuma.

Uko Itegeko rya nyuma rihagaze ubu

Ku ya 7 Ukuboza 2022, Urukiko rw'Akarere rwa Leta Zunze Ubumwe za Amerika rw'Akarere k'Iburasirazuba bwa Texas rwatanze itegeko mu rubanza RJ Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, rukuraho "Imiburo Isabwa kuriPake z'itabin’Amatangazo” itegeko rya nyuma. Ku ya 21 Werurwe 2024, Urukiko rw’Ubujurire rwa Amerika rw’Urugereko rwa Gatanu rwatanze igitekerezo gihindura Urukiko rw’Akarere, rusanga itegeko rya FDA rihuye n’Itegeko Nshinga rya Mbere. Icyo cyemezo cyasubije urubanza Urukiko rw’Akarere kugira ngo rusuzume ibirego bisigaye by’abarega. Abarega batanze icyifuzo cyo kurekura by’agateganyo ibirego byasubitswe. Ku ya 14 Mutarama 2025, Urukiko rw’Akarere rwatanze itegeko ry’ibanze maze rwimurira itariki ryo gutangira gukurikizwa kugeza igihe urubanza rwa nyuma rutangiriye.

Ubuyobozi ku nganda

Ku ya 12 Nzeri 2024, FDA yasohoye amabwiriza ku nganda asobanura politiki y’ikigo yo kubahiriza itegeko rya nyuma. Ariko, vuba aha, Urukiko rw’Akarere rwategetse FDA gushyira mu bikorwa iryo tegeko, rusubika itariki ryo gutangira gukora kugeza igihe urubanza rwa nyuma ruzatangirira.

 Ibiburira bikenewe kuriPake z'itabin'Amatangazo

Pake z'itabi

Ingano n'aho iherereye - Umuburo usabwa ugomba kuba ugizwe nibura na 50% by'imbere n'inyuma by'ipaki y'itabi (ni ukuvuga impande ebyiri nini cyangwa ubuso bunini bw'ipaki).

 Ku makarito y'itabi, imburi zisabwa zigomba kuba ziri ibumoso bw'imbere n'inyuma by'ikarito kandi zigomba kuba zigizwe nibura na 50% by'ibumoso by'izi mpari. Imburi zisabwa zigomba kugaragara neza ku ipaki kandi zigomba kugaragara neza munsi ya cellophane cyangwa ikindi gipfunyika gisobanutse neza.

Icyerekezo – Umuburo ukenewe ugomba gushyirwa ku buryo inyandiko y'umuburo ukenewe n'andi makuru ari kuri iyo paki bigira icyerekezo kimwe.

 Urugero, niba igice cy'imbere cyaipaki y'itabiikubiyemo amakuru, nk'izina ry'ikirango cy'itabi, mu cyerekezo ibumoso ugana iburyo, umuburo usabwa, harimo n'inyandiko y'umuburo, igomba kandi kugaragara mu cyerekezo ibumoso ugana iburyo.

Kugaragaza no gukwirakwiza ku buryo butunguranye no ku buryo bungana – Imburo zose 11 zisabwa ku mapaki zigomba kwerekwa ku buryo butunguranye muri buri mezi 12, inshuro zingana zishoboka kuri buri kirango cy’ibicuruzwa kandi zigakwirakwizwa ku buryo butunguranye mu turere twose twa Leta Zunze Ubumwe za Amerika aho ibicuruzwa bicururizwa, hakurikijwe gahunda yemewe na FDA.

Imburo zidakurwaho cyangwa zihoraho – Imburo zisabwa zigomba gusomwa ku buryo budasibangana cyangwa gushyirwa ku buryo buhoraho kuriipaki y'itabi.

 Urugero, izi mbuzi zisabwa ntizigomba gucapwa cyangwa gushyirwa ku kirango gishyizwe ku gipfunyika cy’inyuma gisobanutse gishobora gukurwaho kugira ngo ibicuruzwa bigere ku gipfunyika.

Amatangazo y'itabi (Pake z'itabi)

Ingano n'aho iherereye – Ku matangazo yacapwe n'andi matangazo afite igice cy'amashusho (harimo, urugero, amatangazo ku byapa, amatangazo y'ubucuruzi, imbuga za interineti, imbuga nkoranyambaga, urubuga rwa elegitoroniki, porogaramu zigendanwa, n'ubutumwa bwa imeri), umuburo ukenewe ugomba kugaragara neza ku itangazo. Byongeye kandi, umuburo ukenewe ugomba kuba ugizwe nibura na 20% by'ubuso bw'itangazo mu buryo bugaragara kandi bugaragara n'ahantu hejuru ya buri tangazo mu gace kometseho, niba hari.

Guhinduranya - Imburo 11 zisabwa zigomba guhindurwa buri gihembwe, mu buryo bukurikiranye, mu matangazo ya buri bwoko bw'itabi, hakurikijwe gahunda yemewe na FDA.

Imburo zidakurwaho cyangwa zihoraho – Imburo zisabwa zigomba gusomwa ku buryo budasibangana cyangwa gushyirwa ku itangazo ry’itabi burundu.

Gahunda z'itabi ku birebana n'uburinzi bukenewe

Ingingo ya 4 y’Itegeko Nshinga rya FCLAA, nk’uko ryavuguruwe na TCA, hamwe n’itegeko rya nyuma risaba abakora itabi, abacuruza, n’abagurisha itabi gutanga gahunda yo kwerekana no gukwirakwiza umuburo usabwa ku mapaki y’itabi mu buryo butunguranye kandi bungana, no guhinduranya buri gihembwe umuburo usabwa mu matangazo y’itabi, no kubona icyemezo cya FDA ku migambi yabo mbere yuko ibicuruzwa bisabwa kugira ngo bihabwe uwo muburo byinjira ku isoko.

 FDA yasohoye "Itangazo ry'igenamigambi ryaPake z'itabin'amabwiriza yo kwamamaza itabi (yavuguruwe)” kugira ngo bifashe abatanga gahunda z'itabi kuriamapaki y'itabin'amatangazo.

 Ibisabwa kugira ngo habeho gahunda yo gutanga itabi kuamapaki y'itabin'amatangazo, hamwe n'ibisabwa byihariye bijyanye no kwerekana no gukwirakwiza umuburo usabwa ku bipfunyika by'itabi mu buryo butunguranye kandi bungana ndetse no gusimburanya buri gihembwe umuburo usabwa mu kwamamaza itabi, bigaragara mu Gika cya 4 (c) cya FCLAA na 21 CFR 1141.10.