LLC PHARMACOR PRODUCTION · 99-39 · RUSSIA

Product code, Product and FDA notes

41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 02/23/2024 Desc: DIETARY SUPPLEMENT VLADONIX Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the label fails to declare each ingredient by its common or usual name [21 CFR 101.4]. - Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. - Section 403(r)(6) because the inner booklet insert makes structure/function claims but fails to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 02/23/2024 Desc: DIETARY SUPPLEMENT VLADONIX Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: - Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the presentation of the nutrition information on the labels does not comply with 21 CFR 101.36. - Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] because the label fails to declare each ingredient by its common or usual name [21 CFR 101.4]. - Section 403(f) of the Act [21 U.S.C. §343(f)] because the product label contains information in two languages but does not repeat all the required information in both languages. - Section 403(r)(6) because the inner booklet insert makes structure/function claims but fails to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).