A ranar 9 ga Mayu, 2022, ainihin sanarwar FDA ta jera Glanbia Performance Nutrition (Manufacturing) Inc. a cikin kamfanonin da suka karɓi wasiƙun gargaɗi.A cikin sanarwar da aka sabunta da aka buga a ranar 10 ga Mayu, 2022, an cire Glanbia daga sanarwar FDA kuma ba a cikin jerin sunayen kamfanonin da ke karɓar wasiƙun gargaɗi.
Silver Spring, MD-Hukumar Abinci da Magunguna (FDA) ta fitar da wasiƙun gargaɗi ga kamfanoni 11 don siyar da ɓarna na abinci.FDA ta ruwaito cewa ana aika wasiku saboda dalilai daban-daban, gami da:
Wasu karikan sun ƙunshi sabbin kayan abinci na abinci (NDI) waɗanda hukumar ba ta karɓi sanarwar NDI na farko da ake buƙata ba.
Wasu daga cikin abubuwan kari kuma magunguna ne, duk da rashin amincewa, saboda an yi nufin amfani da su wajen warkarwa, ragewa, jiyya, ko rigakafin cututtuka.Ƙarƙashin Dokar Abinci, Drug, da Kayan kwalliya ta Tarayya, samfuran da aka yi niyya don ganowa, warkewa, magani, ragewa, ko rigakafin cuta magunguna ne kuma suna ƙarƙashin buƙatun da suka shafi magunguna, koda kuwa an lakafta su azaman kari na abinci, kuma gabaɗaya suna buƙata. kafin amincewa daga FDA.
Wasu daga cikin abubuwan kari ana yi musu alama don abubuwan da ba su da tsaro na abinci.
An aika wasiƙun gargaɗi zuwa:
- Advanced Nutritional Supplements, LLC
- Keɓaɓɓen Kayayyakin Gina Jiki, LLC (Labs Baƙin Dragon)
- Assault Labs
- IronMag Labs
- Killer Labz (Performax Labs Inc)
- Complete Nutrition LLC
- Max tsoka
- Kamfanin Abinci na New York (Amurka Metabolix)
- Kasuwancin Abinci da Sabis na Abokin Ciniki LLC
- Steel Supplements, Inc.
FDA ta ba da rahoton cewa kariyar da kamfanonin da aka jera a sama suka sayar sun ƙunshi ɗaya ko fiye na masu zuwa:
- 5-alpha-hydroxy-laxogenin
- higenamine
- higenamine HCl
- hordenine
- hordenine HCl
- octopamine.
FDA ta lura cewa ya tayar da damuwa game da yawancin waɗannan sinadaran, kuma ya nuna yiwuwar tasirin higenamine akan tsarin zuciya.
Hukumar ta kara da cewa ba ta tantance ko kayayyakin da ba a amince da su ba da ke cikin wannan sabon wasikun gargadi na da tasiri don amfanin da aka yi niyyar amfani da su, ko mene ne ma'aunin da ya dace, da yadda za su iya mu'amala da magungunan da FDA ta amince da su ko wasu abubuwa, ko kuma sun yi tasiri. suna da illa masu haɗari ko wasu matsalolin tsaro.
Kamfanoni da aka yi gargadin suna da kwanaki 15 na aiki don gaya wa FDA yadda za a magance waɗannan batutuwa, ko don ba da dalili da bayanan tallafi da ke bayyana dalilin da ya sa samfuran ba su saba wa doka ba.Rashin samun isasshiyar magance wannan lamari na iya haifar da matakin doka, gami da kama samfur da/ko umarni.
Wannan sabon zagaye na faɗakarwa, wanda aka aika a ranar 9 ga Mayu, ya zo ne kwanaki kaɗan bayan FDA ta aika wasiƙun gargaɗi ga kamfanoni biyar don siyar da samfuran da ke ɗauke da delta-8 tetrahydrocannabinol (delta-8 THC) ta hanyoyin da suka saba wa Abinci na Tarayya, Drug. da Dokar Kayayyaki (Dokar FD&C).Waɗancan wasiƙun suna alama a karon farko da aka ba da gargaɗi ga samfuran da ke ɗauke da delta-8 THC, wanda FDA ta ce yana da tasirin tunani da maye kuma yana iya zama haɗari ga masu amfani.
Lokacin aikawa: Mayu-19-2022