Reference Source

PATANJALI AYURVED LIMITED · 99-39 · INDIA

For PATANJALI AYURVED LIMITED · 99-39 · INDIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is INDIA; product is Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Patanjali Amla Murabba | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice; product code is 20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates | 20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates | 20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates | 20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates | 21 S - - 34 Amla, Subtropical and Tropical Fruit | 21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C. | 24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C. | 24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C. | 24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 02/06/2024; address is Unit III Patanjali Food & Herbal Park , Village Mustafabad, Laksar Road , Haridwar, Uttarakhand INDIA, verified against its source on 2026-09-16.

Firm
PATANJALI AYURVED LIMITED verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
INDIA verified
Address
Unit III Patanjali Food & Herbal Park , Village Mustafabad, Laksar Road , Haridwar, Uttarakhand INDIA verified
Date published
02/06/2024 verified
Product code
20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates | 20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates | 20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates | 20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates | 21 S - - 34 Amla, Subtropical and Tropical Fruit | 21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars | 24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C. | 24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C. | 24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C. | 24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Patanjali Amla Murabba | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice | Amla-Aloevera Juice with Wheat Grass | Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not provided as required by 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in section 403(e)(2) of the Act [21 U.S.C. § 343(e)(1)] and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of U.S. customary units on the principal display panel in accordance with 21 CFR 101.7. The label declares “Net Quantity: 1 kg”. In addition, the label states, “net quantity,” rather than "net weight," 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 in Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Specifically, the ingredients do not appear to be declared by their common or usual name and may not be complete (21 CFR 101.4). The term “amla” is not a common or usual name of an ingredient. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) | 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. each item verified
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PATANJALI AYURVED LIMITED Date Published : 02/06/2024 Unit III Patanjali Food & Herbal Park , Village Mustafabad, Laksar Road , Haridwar, Uttarakhand INDIA 20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 20 D - - 08 Gooseberry Juice, Berry Juice or Concentrates Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 20 D - - 99 Berry Juice, N.E.C. Berry Juice or Concentrates Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 21 S - - 34 Amla, Subtropical and Tropical Fruit Date Published: 12/23/2025 Desc: Patanjali Amla Murabba Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g. Nutrition Facts Panel) is not provided as required by 21 CFR 101.9. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in section 403(e)(2) of the Act [21 U.S.C. § 343(e)(1)] and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA) because the label fails to declare the net quantity of contents in terms of U.S. customary units on the principal display panel in accordance with 21 CFR 101.7. The label declares “Net Quantity: 1 kg”. In addition, the label states, “net quantity,” rather than "net weight," 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 in Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient. Specifically, the ingredients do not appear to be declared by their common or usual name and may not be complete (21 CFR 101.4). The term “amla” is not a common or usual name of an ingredient. 21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 21 V - - 34 Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 21 V - - 37 Bilimbi, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C. Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 24 V - - 99 Leaf & Stem Vegetables, with Sauce, N.E.C. Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C. Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 24 W - - 99 Leaf and Stem Vegetables, Juice or Drink, N.E.C. Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 29 A - - 99 Noncarbonated Soft Drink, N.E.C. Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 29 A - - 99 Noncarbonated Soft Drink, N.E.C. Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/06/2024 Desc: Amla-Aloevera Juice with Wheat Grass 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” which is not commonly used or understood in the U.S. to describe the food. Section 403(a)(1) of the Act. Label bears the false and misleading statement “Aloevera Juice.” Aloe vera ingredients do not meet the regulatory definition of juice. Juice is defined as “the aqueous liquid expressed for extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree.” (21 CFR 120.1(a)) 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 02/06/2024 Desc: Giloy-Amla Juice 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(e)(2) of the Act and 15 U.S.C. 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). The principal display panel does not bear a declaration of the net quantity of contents (21 CFR 101.7). The labels fail to declare the net quantity of contents in terms of U.S. customary units on the principal display panel (15 U.S.C. 1453(a)(2) and (3) of the FPLA. Section 403(f) of the Act. Product labels contain information in two languages but does not repeat all the required label information in both languages (21 CFR 101.15(c)(2)). Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). Based on the product names, the products would be expected to contain additional ingredients. Preservative must be declared individually in the ingredient list by common or usual name (21 CFR 101.4 and 21 CFR 101.22). Section 403(i)(1) of the Act. Statements of identity for both products do not meet the requirements of 21 CFR 101.3(b) because they use foreign terms such as “amla” and “giloy,” which are not commonly used or understood in the U.S. to describe the food.

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