I-FDA Ikhipha Izincwadi Zesexwayiso Eziya Ezinkampanini Ezithengisa I-CBD Ngokungemthetho

Namuhla, i-US Food and Drug Administration ikhiphe izincwadi zesexwayiso eziya ezinkampanini ezinhlanu ngokuthengisa imikhiqizo ebhalwe ukuthi iqukethe i-delta-8 tetrahydrocannabinol (delta-8 THC) ngezindlela ezephula umthetho we-Federal Food, Drug, and Cosmetic Act (FD&C Act). Lesi senzo kungokokuqala ukuthi i-FDA ikhiphe izincwadi eziyisixwayiso ngemikhiqizo equkethe i-delta-8 THC. I-Delta-8 THC inemiphumela yengqondo nedakayo futhi ingaba yingozi kubathengi. I-FDA ithole imibiko yezehlakalo ezingezinhle ezitholwa iziguli ezidle le mikhiqizo.

Azikho izidakamizwa ezigunyazwe yi-FDA eziqukethe i-delta-8 THC. Noma yimuphi umkhiqizo we-delta-8 THC othi uyaxilonga, welapha, uyanciphisa, welapha noma uvimbela izifo uthathwa njengomuthi omusha ongagunyaziwe. I-FDA ayizange ihlole ukuthi ingabe le mikhiqizo yezidakamizwa engagunyaziwe iyasebenza yini kulokho okufunwa ngabakhiqizi, ukuthi umthamo ofanelekile ungaba yini, ingasebenzisana kanjani nezidakamizwa ezigunyazwe i-FDA noma eminye imikhiqizo, noma ingabe inemiphumela emibi eyingozi noma okunye ukukhathazeka kokuphepha.

I-Delta-8 THC ingenye yama-cannabinoids angaphezu kwe-100 akhiqizwa esitshalweni seCannabis sativa L. kodwa ayitholakali ngokwemvelo ngamanani abalulekile. Amanani agxilile e-delta-8 THC ngokuvamile akhiqizwa nge-hemp-derived cannabidiol (CBD) futhi anemiphumela yengqondo nedakayo. Imikhiqizo equkethe i-delta-8-THC itholakala ngezindlela ezihlukene, okuhlanganisa kodwa kungagcini kumaswidi, amakhukhi, okusanhlamvu kwasekuseni, ushokoledi, amagummies, ama-cartridges e-vape (izinqola), ama-dabs, ama-shatter, i-hemp eshunqayo efuthwe ngokukhishwa kwe-delta-8-THC, i-distillate, ama-tinctures, neziphuzo ezifakiwe.

Izincwadi eziyisixwayiso zikhuluma ngokumakethwa okungekho emthethweni kwemikhiqizo engagunyaziwe ye-delta-8 THC yizinkampani njengezindlela zokwelapha ezingagunyaziwe zezimo ezihlukahlukene zezokwelapha noma ezinye izindlela zokwelapha. Izinhlamvu ziphinde ziveze ukwephulwa okuhlobene nokwephulwa kwegama lezidakamizwa (isb., imikhiqizo ayinazo izikhombisi-ndlela ezanele zokusetshenziswa) kanye nokwengezwa kwe-delta-8 THC ekudleni, okufana nezinsini, ushokoledi, ama-caramel, ushingamu, kanye ne-peanut brittle.

“I-FDA ikhathazeke kakhulu ngokuthandwa okukhulayo kwemikhiqizo ye-delta-8 THC ethengiswa ku-inthanethi nasezitolo ezweni lonke. Le mikhiqizo ngokuvamile ihlanganisa izimangalo zokuthi yelapha noma inciphisa imiphumela emibi ehlobene nezinhlobonhlobo zezifo noma izifo zezokwelapha, ezifana nomdlavuza, i-multiple sclerosis, ubuhlungu obungapheli, isicanucanu nokukhathazeka, "kusho iPhini LikaKhomishana Omkhulu we-FDA uJanet Woodcock, MD. Kuyakhathaza kakhulu ukuthi eminye yemikhiqizo yokudla iyapakishwa futhi ibhalwe ngezindlela ezingaheha izingane. Sizoqhubeka nokuvikela impilo nokuphepha kwabantu baseMelika ngokuqapha indawo yemakethe futhi sithathe izinyathelo lapho izinkampani zithengisa ngokungemthetho imikhiqizo ebeka impilo yomphakathi engcupheni.”

I-FDA isanda kushicilela isibuyekezo sabathengi esizwakalisa ukukhathazeka okukhulu mayelana nemiphumela yezempilo engaba khona yemikhiqizo ye-delta-8 THC. I-FDA ithole imibiko yezenzakalo ezimbi ezibandakanya imikhiqizo equkethe i-delta-8 THC evela kubathengi, abasebenzi bezempilo, kanye nabezomthetho, okunye kwakho okubangele isidingo sokulaliswa esibhedlela noma ukwelashwa kwegumbi lezimo eziphuthumayo. I-ejensi iyazi futhi ngenani elandayo lamacala okuchayeka afaka imikhiqizo equkethe i-delta-8 THC etholwe izikhungo zikazwelonke zokulawula ubuthi kanye nezixwayiso ezikhishwe izikhungo zokulawula ubuthi zichaza ukukhathazeka kokuphepha kanye nezenzakalo ezimbi ngemikhiqizo equkethe i-delta-8 THC.

Ngokungeziwe ekwephuleni umthetho okuhlobene nemikhiqizo elawulwa yi-FDA equkethe i-delta-8 THC, ezinye zezincwadi eziyisixwayiso ziveza ukwephulwa okwengeziwe koMthetho we-FD&C, okuhlanganisa ukumaketha imikhiqizo ye-CBD ethi yelapha izimo zezokwelapha kubantu nasezilwaneni, ukukhuthaza imikhiqizo ye-CBD njengezithako zokudla. , kanye nokwengeza i-CBD ekudleni kwabantu nokwezilwane. I-CBD kanye ne-delta-8 THC izithasiselo zokudla ezingagunyaziwe ukuze zisetshenziswe kunoma yimuphi umkhiqizo wokudla womuntu noma wezilwane, njengoba i-FDA ingazi nganoma yisiphi isisekelo sokuphetha ngokuthi izinto ngokuvamile zibonwa njengeziphephile (GRAS) noma ngaphandle kwalokho azikho ezidingweni zokungeza ukudla. Enye yezincwadi izwakalisa ukukhathazeka mayelana nemikhiqizo ye-CBD ekhangiselwe izilwane ezikhiqiza ukudla, kanye nokukhathazeka okungaba khona kwezokuphepha okuhlobene nemikhiqizo yokudla yabantu (isib., inyama, ubisi, amaqanda) ezilwaneni ezidla i-CBD, njengoba kungekho datha mayelana nokuphepha. Amazinga ezinsalela ze-CBD. 

I-FDA ikhiphe izincwadi eziyisixwayiso eziya ku:

• I-ATLRx Inc.

• I-BioMD Plus LLC

• I-Delta 8 Hemp

• I-Kingdom Harvest LLC

• I-M Six Labs Inc.

I-FDA ike yathumela izincwadi zesexwayiso kwezinye izinkampani ezithengisa ngokungemthetho imikhiqizo ye-CBD engagunyaziwe ezithi ziyaxilonga, zelapha, zinciphisa, zelaphe noma zivimbele izifo ezahlukahlukene, ngokwephula uMthetho we-FD&C. Kwezinye izimo, kube nokwephulwa okwengeziwe ngoba i-CBD yengezwe emikhiqizweni yokudla. I-FDA ayizange ivume noma yimiphi imikhiqizo ye-CBD ngaphandle komuthi owodwa owunikezwe udokotela ukuze welaphe izinhlobo ezingavamile, ezinzima zesithuthwane.

I-FDA icele izimpendulo ezibhaliwe ezinkampanini zingakapheli izinsuku eziyi-15 zokusebenza ezisho ukuthi zizobhekana kanjani nalokhu kuphulwa komthetho futhi zivikele ukuphindeka kwakho. Ukwehluleka ukulungisa ngokushesha ukwephulwa komthetho kungase kuphumele esinyathelweni somthetho, okuhlanganisa ukushaqwa komkhiqizo kanye/noma ukuyalelwa.