Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) · 99-39 · MEXICO
For Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) · 99-39 · MEXICO, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is MEXICO; product is Electrolit (all flavors) | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Blueberry Rehydrating Beverage | Electrolit (all flavors) | Electrolit (all flavors) | Electrolit (all flavors) | Blueberry Rehydrating Beverage | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Electrolit (all flavors) | Blueberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Strawberry Rehydrating Beverage | Electrolit (all flavors) | Electrolit (all flavors) | Jamaica Rehydrating Beverage | Strawberry Rehydrating Beverage | Electrolit (all flavors) | Blueberry Rehydrating Beverage | Blueberry Rehydrating Beverage | Electrolit (all flavors) | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Jamaica Rehydrating Beverage | Blueberry Rehydrating Beverage | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Strawberry Rehydrating Beverage | Blueberry Rehydrating Beverage; product code is 20 - - - -- Fruit/Fruit Products | 21 M - - -- Imit Fruit | 21 M - - -- Imit Fruit | 21 M - - -- Imit Fruit | 21 - - - -- Fruit/Fruit Products | 24 - - - -- Vegetables/Vegetable Products | 28 - - - -- Spices, Flavors And Salts | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 - - - -- Drinks, Soft Drinks, and Waters | 30 K - - -- Imit Flav Beverage Base Liq | 30 K - - -- Imit Flav Beverage Base Liq | 30 K - - -- Imit Flav Beverage Base Liq | 30 - - - -- Beverage Bases/Concentrates/Nectars | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 G - - 03 Oral Rehydration Products | 41 G - - 03 Oral Rehydration Products | 41 G - - 03 Oral Rehydration Products | 41 G - - 03 Oral Rehydration Products | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 07/06/2022; address is Carretera San Isidro Mazatepec No. 7000 , Col. Santa Cruz De Las Flores , Tlajomulco De Zuniga, Jalisco MEXICO, verified against its source on 2026-09-16.
- Firm
- Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- MEXICO verified
- Address
- Carretera San Isidro Mazatepec No. 7000 , Col. Santa Cruz De Las Flores , Tlajomulco De Zuniga, Jalisco MEXICO verified
- Date published
- 07/06/2022 verified
- Product code
- 20 - - - -- Fruit/Fruit Products | 21 M - - -- Imit Fruit | 21 M - - -- Imit Fruit | 21 M - - -- Imit Fruit | 21 - - - -- Fruit/Fruit Products | 24 - - - -- Vegetables/Vegetable Products | 28 - - - -- Spices, Flavors And Salts | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 - - - -- Drinks, Soft Drinks, and Waters | 30 K - - -- Imit Flav Beverage Base Liq | 30 K - - -- Imit Flav Beverage Base Liq | 30 K - - -- Imit Flav Beverage Base Liq | 30 - - - -- Beverage Bases/Concentrates/Nectars | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 G - - 03 Oral Rehydration Products | 41 G - - 03 Oral Rehydration Products | 41 G - - 03 Oral Rehydration Products | 41 G - - 03 Oral Rehydration Products | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Electrolit (all flavors) | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Blueberry Rehydrating Beverage | Electrolit (all flavors) | Electrolit (all flavors) | Electrolit (all flavors) | Blueberry Rehydrating Beverage | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Electrolit (all flavors) | Blueberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Strawberry Rehydrating Beverage | Electrolit (all flavors) | Electrolit (all flavors) | Jamaica Rehydrating Beverage | Strawberry Rehydrating Beverage | Electrolit (all flavors) | Blueberry Rehydrating Beverage | Blueberry Rehydrating Beverage | Electrolit (all flavors) | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Jamaica Rehydrating Beverage | Blueberry Rehydrating Beverage | Strawberry Rehydrating Beverage | Jamaica Rehydrating Beverage | Strawberry Rehydrating Beverage | Blueberry Rehydrating Beverage each item verified
- FDA 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). | 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. | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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). | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. each item verified
What the source says
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) Date Published : 07/06/2022 Carretera San Isidro Mazatepec No. 7000 , Col. Santa Cruz De Las Flores , Tlajomulco De Zuniga, Jalisco MEXICO 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 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. 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 - - - -- 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). 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 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. 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). 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: 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 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 - - - -- 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). 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: 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 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: 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 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: 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. 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. 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html