Ma ka lā 9 o Mei, 2022, ua helu ʻia ka hoʻolaha mua a FDA i ka Glanbia Performance Nutrition (Manufacturing) Inc. i waena o nā hui i loaʻa nā leka hoʻolaha.Ma kahi hoʻolaha hou i paʻi ʻia ma Mei 10, 2022, ua wehe ʻia ʻo Glanbia mai ka hoʻolaha ʻana o FDA a ʻaʻole i helu hou ʻia ma waena o nā hui e loaʻa ana nā leka hoʻolaha.
Silver Spring, MD—Ua hoʻopuka ka Food and Drug Administration (FDA) i nā leka hoʻomaopopo i nā hui 11 no ke kūʻai ʻana i nā mea hoʻohui meaʻai moe kolohe.Ua hōʻike ʻo FDA e hoʻouna ʻia ana nā leka no nā kumu like ʻole, me:
Loaʻa i kekahi o nā mea hoʻopihapiha nā meaʻai meaʻai hou (NDIs) i loaʻa ʻole i ke keʻena nā leka hoʻomaopopo NDI mua.
ʻO kekahi o nā mea hoʻohui he mau lāʻau lapaʻau, ʻoiai ʻaʻole i ʻae ʻia, no ka mea, ua manaʻo ʻia no ka hoʻohana ʻana i ka lāʻau lapaʻau, hoʻemi, mālama ʻana, a pale ʻana paha i ka maʻi.Ma lalo o ka Federal Food, Drug, and Cosmetic Act, ʻo nā huahana i manaʻo ʻia e hōʻoia, ho'ōla, mālama, hoʻēmi, a pale paha i nā maʻi he mau lāʻau lapaʻau a pili i nā koi e pili ana i nā lāʻau lapaʻau, ʻoiai inā ua kapa ʻia lākou he mea hoʻohui meaʻai, a koi pinepine. preapproval mai ka FDA.
Ke hōʻailona ʻia nei kekahi o nā mea hoʻohui no nā mea hoʻohui meaʻai palekana.
Ua hoʻouna ʻia nā leka hoʻomaopopo iā:
- Nā meaʻai meaʻai kiʻekiʻe, LLC
- Nā meaʻai meaʻai kūʻokoʻa, LLC (Black Dragon Labs)
- ʻOihana Hoʻouka kaua
- ʻO IronMag Labs
- Killer Labz (Performax Labs Inc)
- Complete Nutrition LLC
- ʻAiʻa Max
- Hui Nutrition New York (American Metabolix)
- Nutritional Sales and Customer Service LLC
- Nā mea hoʻohui kila, Inc.
Ua hōʻike ʻo FDA i nā mea hoʻohui i kūʻai ʻia e nā hui i helu ʻia ma luna nei he hoʻokahi a ʻoi aku paha o kēia mau mea:
- 5-alpha-hydroxy-laxogenin
- higenamine
- higenamine HCl
- hordenine
- hordenine HCl
- octopamine.
Ua ʻike ʻo FDA ua hāpai ʻo ia i nā hopohopo e pili ana i kekahi o kēia mau mea, a kuhikuhi i nā hopena ʻino o ka higenamine ma ka ʻōnaehana cardiovascular.
Ua hoʻohui ka ʻoihana ʻaʻole ia i loiloi inā kūpono nā huahana i ʻae ʻole ʻia e pili ana i kēia pōʻai hou o nā leka ʻōlelo aʻo no ka hoʻohana ʻana, 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 mea ʻē aʻe. loaʻa nā hopena ʻaoʻao weliweli a i ʻole nā pilikia palekana ʻē aʻe.
He 15 mau lā hana nā hui i ʻōlelo ʻia e haʻi i ka FDA pehea e hoʻoponopono ʻia ai kēia mau pilikia, a i ʻole e hāʻawi i ka noʻonoʻo a me ka ʻike kākoʻo e kikoʻī ana i ke kumu ʻaʻole i uhaki ʻia nā huahana i ke kānāwai.ʻO ka hoʻokō pono ʻole ʻana i kēia mea hiki ke hoʻopiʻi i ke kānāwai, me ka hopu ʻana i nā huahana a/a i ʻole ke kauoha.
ʻO kēia pōʻai hope loa o nā ʻōlelo aʻo, i hoʻouna ʻia ma Mei 9, hiki mai i nā lā ma hope o ka hoʻouna ʻana o FDA i nā leka ʻōlelo aʻo i ʻelima hui no ke kūʻai aku ʻana i nā huahana i hōʻailona ʻia me ka delta-8 tetrahydrocannabinol (delta-8 THC) ma nā ala e hōʻino ai i ka Federal Food, Drug, and Cosmetic Act (FD&C Act).ʻO kēlā mau leka e hōʻailona ana i ka manawa mua i hoʻopuka ʻia ai nā ʻōlelo aʻo no nā huahana i loaʻa i ka delta-8 THC, i ʻōlelo ʻia e FDA he hopena psychoactive a ʻona a pilikia paha i nā mea kūʻai.
Ka manawa hoʻouna: Mei-19-2022