Na Mee 9th, 2022, ọkwa izizi FDA depụtara Glanbia Performance Nutrition (Manufacturing) Inc. n'etiti ụlọ ọrụ natara akwụkwọ ozi ịdọ aka na ntị.N'ime ọkwa emelitere nke ebisara na Mee 10, 2022, ewepụrụ Glanbia na ọkwa FDA ma edepụtaghị ya n'etiti ụlọ ọrụ na-anata akwụkwọ ozi ịdọ aka ná ntị.
Silver Spring, MD—Nchịkọta nri na ọgwụ ọjọọ (FDA) enyela ụlọ ọrụ iri na otu akwụkwọ ozi ịdọ aka ná ntị maka ire ihe mgbakwunye nri agbagoro agbarụ.FDA kọrọ na a na-ezigara akwụkwọ ozi maka ebumnuche dị iche iche, gụnyere:
Ụfọdụ n'ime ihe mgbakwunye ahụ nwere ihe oriri ọhụrụ (NDI) nke ụlọ ọrụ ahụ na-enwetaghị ọkwa NDI premarket achọrọ.
Ụfọdụ n'ime ihe mgbakwunye ahụ bụkwa ọgwụ, n'agbanyeghị enweghị nkwado, n'ihi na e bu n'obi mee ya maka ọgwụgwọ, mbelata, ọgwụgwọ, ma ọ bụ igbochi ọrịa.N'okpuru Iwu Federal Food, Drug, and Cosmetic Act, ngwaahịa e zubere ịchọpụta, gwọọ, ọgwụgwọ, ibelata, ma ọ bụ gbochie ọrịa bụ ọgwụ ma dabere n'ihe achọrọ metụtara ọgwụ, ọbụlagodi na akpọnyere ha dị ka mgbakwunye nri, yana n'ozuzu chọrọ. nkwado mbụ sitere na FDA.
A na-edobe ụfọdụ n'ime mgbakwunye ndị ahụ maka mgbakwunye nri adịghị mma.
E zigara leta ịdọ aka ná ntị na:
- Advanced Nutritional Supplements, LLC
- Ngwaahịa Nutrition pụrụiche, LLC (Black Dragọn Labs)
- Ụlọ nyocha mwakpo
- Ụlọ nyocha IronMag
- Killer Labz (Performax Labs Inc)
- Complete Nutrition LLC
- Akwara kachasị
- Ụlọ ọrụ Nutrition New York (American Metabolix)
- Nutritional Sales and Customer Service LLC
- Ụgwọ nke ụlọ ọrụ Steel Supplements, Inc.
FDA kọrọ na mgbakwunye na ụlọ ọrụ ndị edepụtara n'elu rere nwere otu ma ọ bụ karịa n'ime ihe ndị a:
- 5-alfa-hydroxy-laxogenin
- higenamine
- higenamine HCl
- hordenine
- Hordenine HCl
- octopamine.
FDA kwuru na ọ welitere nchegbu banyere ọtụtụ n'ime ihe ndị a, ma rụtụ aka na mmetụta ọjọọ nke higenamine nwere na usoro obi.
Agencylọ ọrụ ahụ gbakwụnyere na enyochabeghị ma ngwaahịa ndị a na-akwadoghị n'okpuru akwụkwọ ozi ịdọ aka ná ntị ọhụrụ a dị irè maka ebumnuche ha, ihe usoro ọgwụgwọ kwesịrị ekwesị nwere ike ịbụ, otu ha nwere ike isi soro ọgwụ FDA kwadoro ma ọ bụ ihe ndị ọzọ, ma ọ bụ ma ha nwere mmetụta dị ize ndụ ma ọ bụ nchegbu nchekwa ndị ọzọ.
Ụlọ ọrụ a dọrọ aka ná ntị nwere ụbọchị ọrụ 15 iji gwa FDA ka a ga-esi edozi okwu ndị a, ma ọ bụ iji nye echiche na nkwado ozi na-akọwa ihe kpatara ngwaahịa ndị ahụ adịghị emebi iwu.Ọdịda ilebara okwu a nke ọma nwere ike bute usoro iwu, gụnyere njide ngwaahịa na/ma ọ bụ iwu.
Oge ịdọ aka ná ntị ọhụrụ a, nke ezigara na Mee 9, na-abịa ụbọchị ole na ole ka FDA zigara ụlọ ọrụ ise akwụkwọ ozi maka ire ngwaahịa akpọrọ delta-8 tetrahydrocannabinol (delta-8 THC) n'ụzọ megidere nri Federal, Drug, na Iwu ịchọ mma (FD&C Act).Akwụkwọ ozi ndị ahụ bụ akara oge izizi ịdọ aka ná ntị maka ngwaahịa nwere delta-8 THC, nke FDA kwuru na ọ nwere mmetụta uche na-egbu egbu ma nwee ike ịdị ize ndụ nye ndị na-azụ ahịa.
Oge nzipu: Mee-19-2022