I-FDA ikhupha iileta zesilumkiso kwiiNkampani ezithengisa iCBD ngokungekho mthethweni

Namhlanje, i-US Food and Drug Administration ikhuphe iileta ezilumkisayo kwiinkampani ezintlanu zokuthengisa iimveliso ezibhalwe njenge-delta-8 tetrahydrocannabinol (delta-8 THC) ngeendlela eziphula umthetho we-Federal Food, Drug, and Cosmetic Act (FD & C Act). Esi senzo sisihlandlo sokuqala ukuba i-FDA ikhuphe iileta ezilumkisayo kwiimveliso eziqulethe i-delta-8 THC. I-Delta-8 THC ineziphumo zengqondo kunye nezinxilisayo kwaye inokuba yingozi kubathengi. I-FDA ifumene iingxelo zeziganeko ezimbi ezifunyenwe zizigulane eziye zasebenzisa ezi mveliso.

Akukho machiza avunywe yi-FDA anedelta-8 THC. Nayiphi na imveliso ye-delta-8 THC ebanga ukuxilonga, ukunyanga, ukuthomalalisa, ukunyanga, okanye ukukhusela izifo ithathwa njengechiza elitsha elingavunywanga. I-FDA ayizange ivavanye ukuba ngaba ezi mveliso zamachiza ezingavunywanga ziyasebenza kubavelisi abasebenzisa ibango, yintoni idosi efanelekileyo, banokusebenzisana njani namachiza avunywe yi-FDA okanye ezinye iimveliso, okanye ukuba zineziphumo ezibi eziyingozi okanye ezinye iinkxalabo zokhuseleko.

I-Delta-8 THC yenye yee-cannabinoids ezingaphezulu kwe-100 eziveliswe kwisityalo seCannabis sativa L. kodwa ayifumaneki ngokwendalo ngezixa ezibalulekileyo. Izixa ezigxininisiweyo ze-delta-8 THC ziqhele ukwenziwa kwi-hemp-derived cannabidiol (CBD) kwaye zineziphumo zengqondo kunye nezinxilisayo. Iimveliso eziqulathe i-delta-8-THC zifumaneka ngeendlela ezahlukeneyo, kubandakanywa kodwa kungaphelelanga kwilekese, iikuki, ukutya okuziinkozo kwisidlo sakusasa, itshokolethi, iigummies, iikhatriji zevape (iinqwelo), iidabs, shatter, ihemp eqhumayo etshizwe nge-delta-8-THC extract, idistillate, tinctures, kunye neziselo ezigalelweyo.

Iileta ezilumkisayo zijongana nokuthengiswa okungekho mthethweni kweemveliso ze-delta-8 ze-THC ezingavunywanga ziinkampani njengonyango olungavunywanga kwiimeko ezahlukeneyo zonyango okanye ezinye iindlela zonyango. Iileta zikwakhankanya ukunyhashwa kweziyobisi okunxulumene nokuthengiswa kakubi kweziyobisi (umzekelo, iimveliso azinamkhomba-ndlela owaneleyo wokusetyenziswa) kunye nokongezwa kwe-delta-8 THC ekutyeni, okufana neentsini, itshokolethi, iikaramels, itshungama kunye ne-peanut brittle.

“I-FDA ixhalabile ngokukhula kokuthandwa kweemveliso ze-delta-8 ze-THC ezithengiswa kwi-Intanethi nakwiivenkile kuzwelonke. Ezi mveliso zihlala zibandakanya amabango okuba baphatha okanye banciphise imiphumo echaphazelekayo enxulumene neentlobo ezininzi zezifo okanye ukuphazamiseka kwezonyango, njengomhlaza, i-multiple sclerosis, intlungu engapheliyo, isicaphucaphu kunye nokuxhalaba, "watsho i-FDA iSekela likaKomishinala uJanet Woodcock, MD. Ikhathaza kakhulu into yokuba ezinye zeemveliso zokutya zipakishwe kwaye zibhalwe ngeendlela ezinokuthi zibe nomtsalane ebantwaneni. Siza kuqhubeka nokukhusela impilo nokhuseleko lwabantu baseMelika ngokubeka iliso kwindawo yentengiso kwaye sithathe amanyathelo xa iinkampani zithengisa ngokungekho mthethweni iimveliso ezibeka umngcipheko kwimpilo yoluntu. ”

I-FDA isandula ukupapasha uhlaziyo lwabathengi evakalisa iinkxalabo ezinzulu malunga neziphumo zempilo ezinokubakho kwiimveliso ze-delta-8 ze-THC. I-FDA ifumene iingxelo zesiganeko esibi ezibandakanya imveliso equkethe i-delta-8 THC evela kubathengi, oogqirha bezempilo, kunye nokunyanzeliswa komthetho, ezinye zazo ezibangele isidingo sokulaliswa esibhedlele okanye unyango lwegumbi likaxakeka. I-arhente nayo iyazi ngokunyuka kwenani lamatyala okuvezwa abandakanya iimveliso eziqulethe i-delta-8 THC efunyenwe ngamaziko olawulo lwetyhefu kazwelonke kunye nezilumkiso ezikhutshwe ngamaziko olawulo lwetyhefu karhulumente achaza iinkxalabo zokhuseleko kunye neziganeko ezimbi kunye neemveliso eziqulethe i-delta-8 THC.

Ukongeza kulwaphulo-mthetho olunxulumene neemveliso ezilawulwa yi-FDA eziqulethe i-delta-8 THC, iileta ezininzi zesilumkiso zichaza ukwaphulwa okungaphezulu koMthetho we-FD&C, kubandakanya ukuthengisa iimveliso ze-CBD ezibanga ukunyanga iimeko zonyango ebantwini nakwizilwanyana, ukukhuthaza iimveliso ze-CBD njengezongezo zokutya. , kunye nokongeza i-CBD ekutyeni kwabantu kunye nezilwanyana. I-CBD kunye ne-delta-8 THC zizongezo zokutya ezingavunywanga ukuba zisetyenziswe kuyo nayiphi na imveliso yokutya yomntu okanye yezilwanyana, njengoko i-FDA ingazi nasiphi na isiseko sokugqiba ukuba izinto zibonwa njengekhuselekile (GRAS) okanye ngenye indlela zikhululwe kwiimfuno ezongezo zokutya. Enye yeeleta ivakalisa inkxalabo malunga neemveliso ze-CBD ezithengiselwa izilwanyana ezivelisa ukutya, kunye neenkxalabo zokhuseleko ezinokubakho ezinxulumene neemveliso zokutya kwabantu (umzekelo, inyama, ubisi, amaqanda) kwizilwanyana ezisebenzisa i-CBD, njengoko kukho ukunqongophala kwedatha ngokukhuselekileyo. Amanqanaba entsalela ye-CBD. 

I-FDA ikhuphe iileta ezilumkisayo eziya:

• ATLRx Inc.

• BioMD Plus LLC

• Delta 8 Hemp

• Kingdom Harvest LLC

• M Six Labs Inc.

I-FDA ngaphambili yathumela iileta ezilumkisayo kwezinye iinkampani ezithengisa ngokungekho mthethweni iimveliso ze-CBD ezingavunywanga ezithi zixilonge, zinyange, zithomalalisa, zinyange okanye zithintele izifo ezohlukeneyo, ngokuchasene noMthetho we-FD&C. Kwezinye iimeko, bekukho ukwaphulwa okungaphezulu kuba i-CBD yongezwa kwiimveliso zokutya. I-FDA ayizivumanga naziphi na iimveliso ze-CBD ngaphandle kwemveliso yeyeza lomntu enye yokunyanga ezinqabileyo, iindlela ezinzima zokuxhuzula.

I-FDA icele iimpendulo ezibhaliweyo kwiinkampani ngaphakathi kweentsuku ze-15 zokusebenza ezichaza indlela abaza kujongana ngayo nezi ziphulwa kunye nokukhusela ukuphindaphinda kwabo. Ukungaphumeleli ukujongana nolwaphulo-mthetho ngokukhawuleza kungakhokelela kwisenzo somthetho, kuquka ukuthinjwa kwemveliso kunye/okanye umyalelo.