BULLION GO-NEAT GLOBAL LTD · 66-41 · NIGERIA

Product code, Product and FDA notes

54 A - - -- Vitamin Date Published: 03/06/2024 Desc: Coco Samba Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 54 C - - -- Protein Date Published: 03/06/2024 Desc: Coco Samba Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 03/06/2024 Desc: Coco Samba Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 61 - - - -- Human and Animal Drugs Date Published: 03/06/2024 Desc: Coco Samba Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. 66 V - - -- Patent Medicines, Etc Date Published: 03/06/2024 Desc: Coco Samba Notes: Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. There is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Misbranded under Section 502(o) of the FD&C Act and unapproved new drugs in violation of 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application.