Ngomhla wesi-9 kuCanzibe, ngo-2022, isibhengezo sokuqala se-FDA sadwelisa iGlanbia Performance Nutrition (Manufacturing) Inc. phakathi kweenkampani ezifumene iileta ezilumkisayo.Kwisibhengezo esihlaziyiweyo esithunyelwe nge-10 kaMeyi, 2022, iGlanbia yasuswa kwisibhengezo se-FDA kwaye ayisadweliswa phakathi kweenkampani ezifumana iileta ezilumkisayo.
Silver Spring, MD-The Food and Drug Administration (FDA) ikhuphe iileta ezilumkisayo kwiinkampani ezili-11 ngokuthengisa izongezo zokutya ezigqwethiweyo.I-FDA inike ingxelo yokuba iileta zithunyelwa ngezizathu ezahlukeneyo, kubandakanya:
Ezinye zezongezelelo ziqulethe izithako ezitsha zokutya (NDIs) apho i-arhente engazange ifumane i-premarket ye-NDI izaziso ezifunekayo.
Ezinye zezongezelelo zikwangamachiza, nangona kungekho mvume, kuba zenzelwe ukusetyenziswa kunyango, ukuthomalalisa, unyango, okanye uthintelo lwezifo.Phantsi kweFederal Food, Drug, and Cosmetic Act, iimveliso ezijonge ukuxilonga, ukunyanga, ukunyanga, ukunciphisa, okanye ukuthintela isifo ngamachiza kwaye zixhomekeke kwiimfuno ezisebenza kumachiza, nokuba zibhalwe njengezongezo zokutya, kwaye zifuna ngokubanzi. imvume yangaphambili evela kwi-FDA.
Ezinye zezongezo zifakwe iflegi yezongezo zokutya ezingakhuselekanga.
Iileta ezilumkisayo zathunyelwa ku:
- Izongezo zeZondlo eziPhezulu, LLC
- IiMveliso zeSondlo eziKhethekileyo, i-LLC (i-Black Dragon Labs)
- IiLebhu zoHlaselo
- IronMag Labs
- Killer Labz (Performax Labs Inc)
- Gqibezela iSondlo LLC
- Ubukhulu bezihlunu
- Inkampani yeSondlo yaseNew York (iMetabolix yaseMelika)
- Intengiso yeZondlo kunye neNkonzo yabaThengi LLC
- Steel Supplements, Inc.
I-FDA ichaze ukuba izongezo ezithengiswayo ziinkampani ezidweliswe ngasentla ziqulethe enye okanye ngaphezulu kwezi zilandelayo:
- I-5-alpha-hydroxy-laxogenin
- ihigenamine
- ihigenamine HCl
- hordenine
- hordenine HCl
- octopamine.
I-FDA yaqaphela ukuba iphakamise inkxalabo malunga nezininzi zezi zithako, kwaye yabonisa iziphumo ezibi ezinokuthi zibe ne-higenamine kwinkqubo ye-cardiovascular system.
I-arhente yongeze ukuba ayikhange ivavanye ukuba ngaba iimveliso ezingavunywanga eziphantsi kolu jikelezo lwamva nje lweeleta zesilumkiso ziyasebenza kusetyenziso olucetyiweyo, ukuba idosi efanelekileyo inokuba yintoni, inokunxibelelana njani namachiza avunywe yi-FDA okanye ezinye izinto, okanye nokuba zithini na. zineziphumo ebezingalindelekanga eziyingozi okanye ezinye iinkxalabo zokhuseleko.
Iinkampani ezilumkileyo zineentsuku zokusebenza ezili-15 zokuxelela i-FDA ukuba le miba iya kuqwalaselwa njani na, okanye ukubonelela ngengqiqo kunye nolwazi oluxhasayo oluchaza ukuba kutheni iimveliso zingaphuli mthetho.Ukungaphumeleli ukulungisa ngokufanelekileyo lo mba kunokubangela ukuba kuthathwe amanyathelo asemthethweni, kubandakanywa ukuthinjwa kwemveliso kunye/okanye umyalelo womthetho.
Lo mjikelo wamva nje wezilumkiso, owathunyelwa nge-9 kaMeyi, uza emva kweentsuku nje emva kokuba i-FDA ithumele iileta ezilumkisayo kwiinkampani ezintlanu ngokuthengisa iimveliso ezibhalwe njenge-delta-8 tetrahydrocannabinol (delta-8 THC) ngeendlela eziphula i-Federal Food, Drug, kunye noMthetho weCosmetic (FD&C Act).Ezo nobumba ziphawula okokuqala izilumkiso zikhutshiwe kwiimveliso eziqulathe i-delta-8 THC, i-FDA yathi ineziphumo zengqondo kunye nezinxilisayo kwaye zinokuba yingozi kubathengi.
Ixesha lokuposa: May-19-2022