Ku ya 9 Gicurasi 2022, itangazo ryambere rya FDA ryashyize ahagaragara Glanbia Performance Nutrition (Manufacturing) Inc. mubigo byakiriye amabaruwa yo kuburira.Mu itangazo rivuguruye ryashyizwe ahagaragara ku ya 10 Gicurasi 2022, Glanbia yakuwe mu itangazo rya FDA kandi ntikiri ku rutonde rw’amasosiyete yakira amabaruwa yo kuburira.
Silver Spring, MD - Ikigo gishinzwe ibiryo n'ibiyobyabwenge (FDA) cyatanze amabaruwa yo kuburira ibigo 11 byo kugurisha inyongeramusaruro.FDA yatangaje ko amabaruwa yoherezwa kubwimpamvu zitandukanye, harimo:
Bimwe mubyongeweho birimo ibintu bishya byimirire (NDIs) ikigo kitabonye imenyekanisha risabwa rya NDI.
Bimwe mubyongeweho kandi nibiyobyabwenge, nubwo bitemewe, kuko bigenewe gukoreshwa mugukiza, kugabanya, kuvura, cyangwa gukumira indwara.Mu mategeko agenga ibiribwa, ibiyobyabwenge, no kwisiga, ibicuruzwa bigamije gusuzuma, gukiza, kuvura, kugabanya, cyangwa gukumira indwara ni ibiyobyabwenge kandi bigengwa n’ibisabwa ku biyobyabwenge, kabone niyo byaba byanditseho ibyokurya, kandi muri rusange birasaba kwemerwa kuva muri FDA.
Bimwe mubyongeweho biri kumanikwa kubintu byongera ibiryo bidafite umutekano.
Amabaruwa yo kuburira yoherejwe kuri:
- Ibiryo byuzuye byintungamubiri, LLC
- Ibiribwa bidasanzwe, LLC (Laboratoire Yumukara)
- Laboratoire yibitero
- Laboratoire ya IronMag
- Umwicanyi Labz (Performax Labs Inc)
- Imirire yuzuye LLC
- Imitsi
- Isosiyete ishinzwe imirire ya New York (Metabolix y'Abanyamerika)
- Kugurisha imirire hamwe na serivisi zabakiriya LLC
- Amashanyarazi, Inc.
FDA yatangaje ko inyongera zagurishijwe n’amasosiyete yavuzwe haruguru zirimo kimwe cyangwa byinshi muri ibi bikurikira:
- 5-alpha-hydroxy-laxogenin
- higenamine
- higenamine HCl
- hordenine
- hordenine HCl
- octopamine.
FDA yavuze ko yazamuye impungenge kuri byinshi muri ibyo bikoresho, ikanerekana ingaruka mbi za higenamine kuri sisitemu yumutima.
Ikigo cyongeyeho ko kitigeze gisuzuma niba ibicuruzwa bitemewe bigengwa n’uruhererekane rw’amabaruwa yo kuburira bifite akamaro mu kubikoresha, uko urugero rukwiye rushobora kuba, uburyo bishobora gukorana n’ibiyobyabwenge byemewe na FDA cyangwa ibindi bintu, cyangwa niba aribyo ufite ingaruka mbi cyangwa izindi mpungenge z'umutekano.
Ibigo biburira bifite iminsi 15 yakazi yo kubwira FDA uko ibyo bibazo bizakemuka, cyangwa gutanga ibitekerezo no gushyigikira amakuru arambuye kubicuruzwa bitanyuranyije n amategeko.Kunanirwa gukemura bihagije iki kibazo bishobora kuvamo amategeko, harimo gufata ibicuruzwa na / cyangwa icyemezo.
Iki cyiciro giheruka cyo kuburira, cyoherejwe ku ya 9 Gicurasi, kije nyuma yiminsi mike FDA yohereje amabaruwa yo kuburira ibigo bitanu byo kugurisha ibicuruzwa byanditseho ko birimo delta-8 tetrahydrocannabinol (delta-8 THC) muburyo bunyuranyije n’ibiribwa rusange, ibiyobyabwenge, n'amategeko yo kwisiga (itegeko rya FD&C).Izo nzandiko zigaragaza ku nshuro ya mbere imburi zitangwa ku bicuruzwa birimo delta-8 THC, FDA yavuze ko ifite ingaruka zo mu mutwe kandi zisindisha kandi zishobora guteza akaga abaguzi.
Igihe cyoherejwe: Gicurasi-19-2022