• FDA Requests Information Relevant to the Use of NAC as a Dietary Supplement

I-FDA Icela Ulwazi Oluhlobene Nokusetshenziswa Kwe-NAC Njengesengezo Sokudla

Ngomhla ka-Nov. 24, 2021, i-Food and Drug Administration (FDA) yakhipha isicelo solwazi mayelana nokusetshenziswa okwedlule kwe-N-acetyl-L-cysteine ​​(NAC) emikhiqizweni emakethe njengezithako zokudla, okuhlanganisa: idethi yakuqala i-NAC. yathengiswa njengesengezo sokudla noma njengokudla, ukusetshenziswa okuphephile kwe-NAC emikhiqizweni emakethe njengesengezo sokudla, kanye nanoma yikuphi ukukhathazeka ngokuphepha.I-FDA icela abathintekayo ukuthi balethe ulwazi olunjalo ngoJanuwari 25, 2022.

NgoJuni 2021, i-Council for Responsible Nutrition (CRN) yacela i-FDA ukuthi iguqule isimo se-ejensi sokuthi imikhiqizo equkethe i-NAC ayikwazi ukuba izithasiselo zokudla.Ngo-Agasti 2021, i-Natural Products Association (NPA) yacela i-FDA ukuthi inqume ukuthi i-NAC ayikhishiwe encazelweni yesithasiselo sokudla noma, ngokunye, iqalise umthetho wokwenza i-NAC ibe isithasiselo sokudla esisemthethweni ngaphansi kwe-Federal Food, Drug. , kanye ne-Cosmetic Act.

Njengempendulo evivinyayo kuzo zombili izicelo zezakhamizi, i-FDA icela ulwazi olwengeziwe kubafakisicelo kanye nezinhlangano ezinentshisekelo ngenkathi iphawula ukuthi i-ejensi idinga isikhathi esengeziwe ukuze ibuyekeze ngokucophelela nangokucophelela imibuzo eyinkimbinkimbi ebuzwa kulezi zikhalazo.

 

Uyini Umkhiqizo Wokungezelela Wokudla kanye Nesithako?

I-FDA ichaza izithasiselo zokudla njengemikhiqizo (ngaphandle kukagwayi) okuhloswe ngayo ukwengeza ekudleni okuqukethe okungenani isithako esisodwa kwezilandelayo: uvithamini, amaminerali, i-amino acid, imifino noma enye i-botanical;ukudla okuzosetshenziswa ngumuntu ukwengeza ekudleni ngokwandisa inani eliphelele lokudla;noma i-concentrate, metabolite, constituent, extract, noma inhlanganisela yezinto ezandulele.Angase atholakale ngezindlela eziningi njengamaphilisi, amaphilisi, amaphilisi, noma uketshezi.Kungakhathaliseki ukuthi zinjani, azisoze zathatha indawo yokudla okuvamile noma ukudla okukodwa noma ukudla.Kudingeka ukuthi zonke izithasiselo zibhalwe “njengesengezo sokudla”.

Ngokungafani nezidakamizwa, izithasiselo azihloselwe ukwelapha, ukuxilonga, ukuvimbela, noma ukwelapha izifo.Lokho kusho ukuthi izithasiselo akufanele zenze izimangalo, njengokuthi "nciphisa ubuhlungu" noma "ukwelapha isifo senhliziyo."Izimangalo ezinjengalezi zingenziwa kuphela ngokusemthethweni ezidakamizweni, hhayi izithasiselo zokudla.

 

Imithethonqubo Yezithako Zokudla

Ngaphansi Komthetho Wezempilo Nezemfundo Okwengeziwe Kwezokudla ka-1994 (DSHEA):

Abakhiqizi nabasabalalisi bezithako zokudla kanye nezithako zokudla abavunyelwe emikhiqizweni yokumaketha eyonakele noma enamagama angafanele.Lokhu kusho ukuthi lezi zinkampani zinesibopho sokuhlola ukuphepha nokulebula kwemikhiqizo yazo ngaphambi kokumaketha ukuze ziqinisekise ukuthi ziyahlangabezana nazo zonke izidingo ze-FDA ne-DSHEA.

I-FDA inegunya lokuthatha isinyathelo ngokumelene nanoma yimuphi umkhiqizo wezokudla ophikisiwe noma onegama elingafanele ngemva kokuba usufinyelele emakethe.


Isikhathi sokuthumela: Mar-15-2022
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