Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) · 99-39 · MEXICO

Product code, Product and FDA notes

20 - - - -- Fruit/Fruit Products Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 21 - - - -- Fruit/Fruit Products Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 21 M - - -- Imit Fruit Date Published: 07/06/2022 Desc: Blueberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 21 M - - -- Imit Fruit Date Published: 07/06/2022 Desc: Strawberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 21 M - - -- Imit Fruit Date Published: 07/06/2022 Desc: Jamaica Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 24 - - - -- Vegetables/Vegetable Products Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 28 - - - -- Spices, Flavors And Salts Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 29 - - - -- Drinks, Soft Drinks, and Waters Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 07/06/2022 Desc: Blueberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 07/06/2022 Desc: Strawberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 07/06/2022 Desc: Jamaica Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 30 - - - -- Beverage Bases/Concentrates/Nectars Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 30 K - - -- Imit Flav Beverage Base Liq Date Published: 07/06/2022 Desc: Blueberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 30 K - - -- Imit Flav Beverage Base Liq Date Published: 07/06/2022 Desc: Strawberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 30 K - - -- Imit Flav Beverage Base Liq Date Published: 07/06/2022 Desc: Jamaica Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 41 G - - 03 Oral Rehydration Products Date Published: 07/06/2022 Desc: Blueberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 41 G - - 03 Oral Rehydration Products Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 41 G - - 03 Oral Rehydration Products Date Published: 07/06/2022 Desc: Strawberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 41 G - - 03 Oral Rehydration Products Date Published: 07/06/2022 Desc: Jamaica Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 07/06/2022 Desc: Blueberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 10/14/2022 Desc: Electrolit (all flavors) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1] in that the product labels have two inconsistent statements of identity for the same product. Section 403(a)(1)/201(n) in that the product labels fail to reveal the material fact that the identified flavor is artificially derived. Section 403(f) because their labels contain information in a second language, Spanish; therefore, all required information must be in both languages. Section 403(q) in that the nutrition information (e.g. Nutrition Facts label) is not as required by 21 CFR 101.9(c)(8)(ii). 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 07/06/2022 Desc: Strawberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 07/06/2022 Desc: Jamaica Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/06/2022 Desc: Blueberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/06/2022 Desc: Strawberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/06/2022 Desc: Jamaica Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/06/2022 Desc: Blueberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/06/2022 Desc: Jamaica Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 07/06/2022 Desc: Strawberry Rehydrating Beverage Notes: The article is 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(i)(2), of the Act in that each ingredient is not declared by its common or usual name (21 CFR 101.4). Missing ingredient statement, such as water, glucose, and flavors. Section 403(e)(2) and 15 USC 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) missing net quantity of contents in U.S. customary units for fluid measure (21 CFR 101.7(b)(2)). 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.