Ku ya 24 Ugushyingo 2021, Ubuyobozi bushinzwe ibiryo n'ibiyobyabwenge (FDA) bwatanze icyifuzo ku makuru ajyanye no gukoresha N-acetyl-L-cysteine (NAC) mu bicuruzwa byashyizwe ku isoko nk'inyongera y'ibiryo, birimo: itariki ya mbere NAC yagurishijwe nk'inyongera y'ibiryo cyangwa nk'ibiryo, gukoresha neza NAC mubicuruzwa byagurishijwe nk'inyongera y'ibiryo, hamwe n'impungenge z'umutekano.FDA irasaba ababishaka gutanga ayo makuru bitarenze 25 Mutarama 2022.
Muri Kamena 2021, Inama ishinzwe imirire ishinzwe (CRN) yasabye FDA guhindura imyumvire y’ikigo ko ibicuruzwa birimo NAC bidashobora kuba inyongera y’imirire.Muri Kanama 2021, Ishyirahamwe ry’ibicuruzwa karemano (NPA) ryasabye FDA kumenya niba NAC idakuwe mu bisobanuro by’inyongera y’imirire cyangwa, mu bundi buryo, gutangiza ibyemezo kugira ngo NAC yongererwe ibiryo byemewe na Federal Food, Drug , hamwe no kwisiga.
Nkigisubizo cyagateganyo kubibazo byombi byabaturage, FDA irasaba amakuru yinyongera kubasabye nababifitemo inyungu mugihe avuga ko ikigo gikeneye igihe cyinyongera cyo gusuzuma neza no gusuzuma neza ibibazo bitoroshye byatanzwe muri ibyo byifuzo.
Nibihe Byokurya Byuzuye Ibicuruzwa & Ibigize?
FDA isobanura inyongeramusaruro nkibicuruzwa (usibye itabi) bigamije kuzuza indyo irimo byibura kimwe mubintu bikurikira: vitamine, imyunyu ngugu, aside amine, ibyatsi cyangwa ibindi bimera;ibiryo byokurya kugirango umuntu akoreshe kugirango yongere ibiryo byongera ibiryo byuzuye;cyangwa kwibanda, metabolite, ibiyigize, gukuramo, cyangwa guhuza ibintu byabanjirije iki.Bashobora kuboneka muburyo bwinshi nkibinini, capsules, ibinini, cyangwa amazi.Imiterere yabo yaba imeze ite, ntishobora na rimwe gusimbuza ibiryo bisanzwe cyangwa ikintu cyonyine cyamafunguro cyangwa indyo.Birasabwa ko inyongera yose yanditseho "inyongera yimirire".
Bitandukanye nibiyobyabwenge, inyongera ntizigenewe kuvura, gusuzuma, gukumira, cyangwa gukiza indwara.Ibyo bivuze ko inyongera zidakwiye gutanga ibisabwa, nka "kugabanya ububabare" cyangwa "kuvura indwara z'umutima."Ibirego nkibi birashobora gutangwa gusa byemewe nibiyobyabwenge, ntabwo byongera ibiryo.
Amabwiriza yinyongera yimirire
Mu Mategeko agenga ubuzima n’uburezi mu 1994 (DSHEA):
Abakora nogukwirakwiza inyongeramusaruro nibigize ibiryo birabujijwe kwamamaza ibicuruzwa byangiritse cyangwa byanditswe nabi.Ibi bivuze ko ibyo bigo bishinzwe gusuzuma umutekano no kuranga ibicuruzwa byabo mbere yo kwamamaza kugirango barebe ko byujuje ibisabwa na FDA na DSHEA.
FDA ifite uburenganzira bwo gufata ingamba zo kurwanya ibiryo byangiritse cyangwa byandujwe nyuma yo kugera ku isoko.
Igihe cyo kohereza: Werurwe-15-2022
