UNIVERSITY OF MAE FAH LUANG · 99-39 · THAILAND

Product code, Product and FDA notes

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Formulated for nerve pain Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Intestinal Cleanser Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Formulated for multiple diseases and regulates body balance Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Formulated for blood pressure and blood sugar balance Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Healthy Heart Support Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Improves energy and overall wellness; For Gentlemen Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Gout Support Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Relieve Hemorrhoids Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/19/2019 Desc: Natural Miracle Herbs brand Toxin Neutralizer Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product labels contain information in multiple languages but does not repeat all required information in all languages, 21 CFR 101.15(c). Section 403(i)(2) of the Act in that the product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).