Hoʻopuka ʻo FDA i nā leka aʻo i nā ʻoihana kūʻai hewa ʻole i ka CBD

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I kēia lā, ua hoʻopuka ka US Food and Drug Administration i nā leka ʻōlelo aʻo i nā hui ʻelima no ke kūʻai aku ʻana i nā huahana i kapa ʻia me ka delta-8 tetrahydrocannabinol (delta-8 THC) ma nā ala e kūʻē ai i ka Federal Food, Drug, and Cosmetic Act (FD&C Act). ʻO kēia hana ka manawa mua i hoʻopuka ai ka FDA i nā leka hoʻomaopopo no nā huahana i loaʻa ka delta-8 THC. Loaʻa i ka Delta-8 THC nā hopena psychoactive a me ka ʻona a pilikia paha i nā mea kūʻai. Ua loaʻa i ka FDA nā hōʻike o nā hanana ʻino i ʻike ʻia e nā maʻi i hoʻopau i kēia mau huahana.

ʻAʻohe lāʻau lapaʻau i ʻae ʻia e FDA me ka delta-8 THC. ʻO kēlā me kēia huahana delta-8 THC e ʻōlelo ana e hōʻoia, hoʻōla, hoʻēmi, mālama, a pale paha i nā maʻi i manaʻo ʻia he lāʻau lapaʻau hou ʻole. ʻAʻole i loiloi ka FDA inā pono kēia mau huahana lāʻau ʻaʻole i ʻae ʻia no ka hoʻohana ʻana i nā mea hana, he aha ke ʻano kūpono, pehea e hiki ai iā lākou ke launa pū me nā lāʻau lapaʻau i ʻae ʻia e FDA a i ʻole nā ​​​​huahana ʻē aʻe, a i ʻole he hopena ʻaoʻao weliweli a i ʻole nā ​​pilikia palekana.

ʻO Delta-8 THC kekahi o nā cannabinoids ma mua o 100 i hana ʻia ma ka lāʻau Cannabis sativa L. akā ʻaʻole ʻike maoli ʻia i nā helu nui. Hana ʻia ka nui o ka delta-8 THC mai ka hemp-derived cannabidiol (CBD) a loaʻa nā hopena psychoactive a ʻona. Loaʻa nā huahana i loaʻa i ka delta-8-THC ma nā ʻano like ʻole, e komo pū ana akā ʻaʻole i kaupalena ʻia i ka candy, nā kuki, ka palaoa ʻaina kakahiaka, ke kokoleka, nā gummies, nā pahu vape (kaʻa), dabs, shatter, hemp smokable i kāpī ʻia me ka delta-8-THC extract, distillate, tinctures, a me nā mea inu i hoʻokomo ʻia.

Hoʻopuka nā leka ʻōlelo aʻo i ke kūʻai ʻole ʻole ʻia o nā huahana delta-8 THC i ʻae ʻole ʻia e nā hui ma ke ʻano he lāʻau lapaʻau ʻaʻole i ʻae ʻia no nā kūlana olakino a i ʻole nā ​​​​mea hoʻohana lapaʻau ʻē aʻe. Hōʻike pū nā leka i nā hewa e pili ana i ka hōʻailona lāʻau lapaʻau (e laʻa, nele nā ​​huahana i nā kuhikuhi kūpono no ka hoʻohana ʻana) a me ka hoʻohui ʻana o delta-8 THC i nā meaʻai, e like me ka gummies, ke kokoleka, caramels, chewing gum, a me ka paʻi pīkī.

"Ke hopohopo nui nei ka FDA e pili ana i ka ulu nui ʻana o nā huahana delta-8 THC i kūʻai ʻia ma ka pūnaewele a ma nā hale kūʻai ma ka ʻāina. Hoʻokomo pinepine kēia mau huahana i nā koi e mālama a hoʻohaʻahaʻa paha lākou i nā hopena ʻaoʻao e pili ana i nā ʻano maʻi like ʻole a i ʻole nā ​​maʻi olakino, e like me ke kanesa, ka maʻi sclerosis lehulehu, ka ʻeha mau, nausea a me ka hopohopo, "wahi a FDA Principal Deputy Commissioner Janet Woodcock, MD "It He mea paʻakikī loa ka hoʻopili ʻia ʻana o kekahi o nā huahana meaʻai a hoʻopaʻa inoa ʻia i nā ʻano e ʻoluʻolu ai nā keiki. E hoʻomau mākou i ka mālama ʻana i ke olakino a me ka palekana o ʻAmelika ma o ka nānā ʻana i ka mākeke a hana i nā hana ke kūʻai aku ʻole nā ​​​​hui i nā huahana e pilikia ai ke olakino lehulehu.

Ua paʻi hou ka FDA i kahi mea kūʻai aku e hōʻike ana i nā hopohopo koʻikoʻi e pili ana i nā hopena olakino o nā huahana delta-8 THC. Ua loaʻa i ka FDA nā hōʻike hanana pōʻino e pili ana i nā huahana i loaʻa i ka delta-8 THC mai nā mea kūʻai aku, nā mea mālama ola kino, a me nā mea hoʻokō kānāwai, ʻo kekahi o ia mau mea i hopena i ka pono o ka hale maʻi a i ʻole ka mālama lumi pilikia. ʻIke pū ka ʻoihana i ka piʻi nui ʻana o nā hihia e pili ana i nā huahana i loaʻa i ka delta-8 THC i loaʻa e nā kikowaena hoʻomalu lāʻau ʻona a me nā mākaʻikaʻi i hoʻopuka ʻia e nā kikowaena hoʻomalu o ka mokuʻāina e wehewehe ana i nā hopohopo palekana a me nā hanana ʻino me nā huahana i loaʻa ka delta-8 THC.

Ma kahi o nā hewa e pili ana i nā huahana i hoʻoponopono ʻia e FDA i loaʻa i ka delta-8 THC, ʻoi aku ka nui o nā leka ʻōlelo aʻoaʻo e hōʻike i nā hewa hou aʻe o ka FD&C Act, me ka kūʻai ʻana i nā huahana CBD e koi ana e mālama i nā kūlana olakino i nā kānaka a me nā holoholona, ​​​​e hoʻolaha ana i nā huahana CBD ma ke ʻano he meaʻai meaʻai. , a me ka hoʻohui ʻana i ka CBD i nā meaʻai kanaka a me nā holoholona. ʻO CBD a me delta-8 THC nā mea hoʻohui meaʻai ʻaʻole i ʻae ʻia no ka hoʻohana ʻana i kekahi huahana meaʻai kanaka a holoholona, ​​​​no ka mea, ʻaʻole ʻike ka FDA i kahi kumu e hoʻoholo ai ua ʻike ʻia nā mea maʻamau he palekana (GRAS) a i ʻole ʻae ʻia mai nā koi hoʻohui meaʻai. ʻO kekahi o nā leka e hōʻike ana i nā hopohopo e pili ana i nā huahana CBD i kūʻai ʻia no nā holoholona hana meaʻai, a me nā hopohopo palekana e pili ana i nā huahana meaʻai kanaka (e laʻa, ka ʻiʻo, ka waiū, nā hua manu) mai nā holoholona e ʻai ana i ka CBD, no ka mea, aia ka nele o ka ʻikepili i ka palekana. CBD koena pae. 

Ua hoʻopuka ka FDA i nā leka hoʻomaopopo iā:

• ATLRx Inc.

• BioMD Plus LLC

• Delta 8 Hemp

• Kingdom Harvest LLC

• M Six Labs Inc.

Ua hoʻouna mua ka FDA i nā leka hoʻolaha i nā ʻoihana ʻē aʻe e kūʻai aku nei i nā huahana CBD ʻaʻole i ʻae ʻia i ʻōlelo ʻia e hōʻoia, ho'ōla, hoʻēmi, mālama a pale aku i nā maʻi like ʻole, me ke kūʻē i ke kānāwai FD&C. I kekahi mau hihia, aia kekahi mau hewa no ka mea ua hoʻohui ʻia ʻo CBD i nā huahana meaʻai. ʻAʻole ʻae ka FDA i nā huahana CBD ʻē aʻe ma mua o hoʻokahi huahana lāʻau lapaʻau kanaka e mālama ai i nā ʻano maʻi epilepsy.

Ua noi ka FDA i nā pane i kākau ʻia mai nā hui i loko o 15 mau lā hana e hōʻike ana pehea lākou e hoʻoponopono ai i kēia mau hewa a pale i kā lākou hana hou ʻana. ʻO ka hiki ʻole ke hoʻoponopono koke i nā hewa e hopena i ka hana kānāwai, me ka hopu ʻana i nā huahana a/a i ʻole ke kauoha.

He aha e lawe ʻia mai kēia ʻatikala:

  • In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.
  • CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements.
  • The agency is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.

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Linda Hohnholz

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