• Ubushobozi bwitabi

Agasanduku k'itabi n'ibisabwa kuburira ubuzima

Umuburo w'ubuzima bw'itabi

Itegeko ryo gukumira no kurwanya itabi ry’umuryango (TCA) ryahaye FDA ububasha bushya bwo kugenzura ibicuruzwa, ibicuruzwa, n’ikwirakwizwa ry’ibicuruzwa by’itabi. TCA kandi yahinduye igice cya 4 cy’amategeko agenga itabi n’iyamamaza (FCLAA), itegeka FDA gutanga amabwiriza asaba ibishushanyo mbonera byerekana ingaruka mbi z’ubuzima bw’itabi riherekeza amagambo mashya yo kuburira. TCA ihindura FCLAA kugirango isabe buriweseipaki y'itabin'amatangazo yo kwihanganira imwe mu miburo mishya isabwa.

 Muri Werurwe 2020, FDA yarangije “Iburira risabwa kuriAmapaki y'itabin'Itangazo "itegeko, rishyiraho umuburo mushya mushya w'ubuzima bw'itabi, ugizwe n'amatangazo yo kuburira inyandiko aherekejwe n'ibishushanyo by'amabara, mu buryo bw'amashusho yerekana amafoto, byerekana ingaruka mbi z’ubuzima ziterwa no kunywa itabi.

 FDA yasohoye kandi "Iburira risabwa kuriAmapaki y'itabino Kwamamaza - Igitabo Gito Cyubahiriza Ubuyobozi "kugirango gifashe imishinga mito gusobanukirwa no kubahiriza amategeko yanyuma.

 agasanduku k'itabi

Imiterere y'ubu y'amategeko yanyuma

Ku ya 7 Ukuboza 2022, Urukiko rw’intara rwo muri Amerika mu karere k’iburasirazuba bwa Texas rwatanze itegeko muri RJ Reynolds Tobacco Co n’abandi. v. Leta zunze ubumwe z’Amerika gishinzwe ibiryo n’ibiyobyabwenge n’abandi, No 6: 20-cv-00176, bivanaho “Iburira risabwa kuriAmapaki y'itabin'Itangazo ". y'urubanza rwa nyuma mu rubanza.

 agasanduku k'itabi

Kuyobora Inganda

Ku ya 12 Nzeri 2024, FDA yatanze ubuyobozi ku nganda zisobanura politiki yo kubahiriza icyo kigo ku itegeko rya nyuma. Icyakora, vuba aha, Urukiko rw'Ibanze rwategetse FDA gushyira mu bikorwa iryo tegeko kandi isubika umunsi w'iri tegeko ritangira gukurikizwa kugeza igihe urubanza rwa nyuma ruzabera.

 Iburira risabwa kuriAmapaki y'itabin'amatangazo

 kwerekana itabi

Amapaki y'itabi

Ingano n'aho biherereye - Iburira risabwa bigomba kuba byibuze byibuze 50 ku ijana hejuru yimbere ninyuma yibipapuro byitabi (nukuvuga impande zombi nini cyangwa hejuru yububiko).

 Ku makarito y itabi, imiburo isabwa igomba kuba iri kuruhande rwibumoso rwimbere ninyuma yikarito kandi igomba kuba byibuze byibuze 50% byibumoso. Umuburo usabwa ugomba kugaragara neza kuri paki kandi ugomba kugaragara neza munsi ya selile iyo ari yo yose cyangwa ibindi bipfunyitse neza.

Icyerekezo - Umuburo usabwa ugomba guhagarikwa kugirango inyandiko yumuburo usabwa hamwe nandi makuru ari kuri iyo panel ya paki afite icyerekezo kimwe.

ikarita y'itabi

 Kurugero, niba imbere yimbere ya aipaki y'itabiikubiyemo amakuru, nk'izina ry'ikirango cy'itabi, ibumoso ugana iburyo, umuburo usabwa, harimo n'amatangazo yo kuburira, ugomba no kugaragara ibumoso ugana iburyo.

Kwerekana no gukwirakwiza bisanzwe kandi bingana - Byose 11 bisabwa kuburira kubipaki bigomba kwerekanwa muburyo butunguranye muri buri gihe cyamezi 12, mugihe kingana ninshuro zishoboka kuri buri kirango cyibicuruzwa kandi bigomba gukwirakwizwa muburyo butandukanye mubice byose byo muri Amerika aho ibicuruzwa bigurishwa, hakurikijwe gahunda y’itabi yemewe na FDA.

Iburira ridasubirwaho cyangwa rihoraho - Imiburo isabwa igomba gucapurwa bidasubirwaho cyangwa gushyirwaho burundu kuriipaki y'itabi.

 Kurugero, iyi miburo isabwa ntigomba gucapwa cyangwa gushyirwa kumurango wometse kumuzingo usobanutse neza ushobora gukurwaho kugirango ubone ibicuruzwa muri paki.

icyatsi kibisi

Amatangazo yamatabi (Amapaki y'itabi

Ingano n'aho biherereye - Kumatangazo yamamaza hamwe nandi matangazo yamamaza agizwe nibintu bigaragara (harimo, nk'urugero, amatangazo ku bimenyetso, kwerekana ibicuruzwa, imbuga za interineti, imbuga nkoranyambaga, imbuga za interineti, porogaramu zigendanwa, hamwe na imeri yandikirwa), umuburo usabwa ugomba kugaragara ku iyamamaza. Byongeye kandi, imiburo isabwa igomba kuba igizwe nibura 20 ku ijana by'ahantu ho kwamamaza mu buryo bugaragara kandi bugaragara kandi biri hejuru ya buri tangazo mu gice cya trim, niba gihari.

Kuzunguruka - Imiburo 11 isabwa igomba kuzunguruka buri gihembwe, muburyo bukurikiranye, mukwamamaza kuri buri kirango cyitabi, hakurikijwe gahunda y’itabi yemewe na FDA.

Imiburo idasubirwaho cyangwa ihoraho - Imiburo isabwa igomba gucapurwa bidasubirwaho cyangwa gushyirwaho burundu kumatabi.

agasanduku k'itabi

Gahunda y'itabi kuburira bikenewe

Igice cya 4 cya FCLAA, nkuko ryavuguruwe na TCA, kandi itegeko rya nyuma risaba abayikora, abayigurisha, n'abacuruza itabi gutanga gahunda yo kwerekana ku buryo butemewe kandi buringaniye no gukwirakwiza imiburo isabwa ku bipfunyika by'itabi no guhinduranya buri gihembwe cy'iburira risabwa mu matangazo y’itabi, no kubona ibyemezo bya FDA byemezwa mbere yuko ibicuruzwa bisabwa kugira ngo bibe byinjira ku isoko.

 FDA yatanze "Gutanga Gahunda yaAmapaki y'itabin'iyamamaza ry'itabi (Byahinduwe) "ubuyobozi bwo gufasha abatanga gahunda y'itabi kuriipakin'amatangazo.

 Ibisabwa kugirango utange gahunda yitabi kuriipakin'amatangazo yamamaza, hamwe nibisabwa byihariye bijyanye no kwerekana no kugereranya no gukwirakwiza imburi zisabwa ku gupakira itabi no kuzenguruka buri gihembwe cyo kuburira mu kwamamaza itabi, bigaragara ku gice cya 4 (c) cya FCLAA na 21 CFR 1141.10.

kwerekana itabi


Igihe cyoherejwe: Gashyantare-27-2025
//