GOLD FOOD RESOURCES SDN BHD · 99-39 · MALAYSIA

Product code, Product and FDA notes

36 C - - 04 Honey Date Published: 03/23/2023 Desc: Black Horse Vital Honey Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL). 36 C - - 99 Honey, N.E.C. Date Published: 03/23/2023 Desc: Black Horse Vital Honey Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 03/23/2023 Desc: Black Horse Vital Honey Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL). 66 S - - 51 Tadalafil Date Published: 03/23/2023 Desc: Black Horse Vital Honey Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act, in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act, in that the product label appears to be false and misleading because of the much larger statement on the Principal Display Panel (PDP) of “Vital Honey” and the honeycomb vignettes give the overall impression that this product is honey. Section 403(e)(1) of the Act, in that the sachets fail to bear a label containing the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5. Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(f) of the Act [21 U.S.C. §343(f)], in that the product label contains information in more than one language but does not repeat all the required information in these languages. Section 403(q) of the Act (21 U.S.C. § 343 (q)), in that the product does not present nutrition information on the labeling, as required by 21 CFR 101.9. Specifically, the product does not contain a Nutrition Facts Label (NFL).