Pablo Francisco Beltran Sanchez · 99-39 · ECUADOR
For Pablo Francisco Beltran Sanchez · 99-39 · ECUADOR, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is ECUADOR; product is Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Plantain Grain (Llanten) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Plantain Grain (Llanten) | Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Plantain Grain (Llanten) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Plantain Grain (Llanten); product code is 31 K - - 99 Tea, N.E.C. | 31 K - - 99 Tea, N.E.C. | 31 K - - 99 Tea, N.E.C. | 31 K - - 99 Tea, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/24/2024; address is Eloy Alfaro Lt 4 & Panamericana Norte , Quito, Pichincha ECUADOR, verified against its source on 2026-09-16.
- Firm
- Pablo Francisco Beltran Sanchez verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- ECUADOR verified
- Address
- Eloy Alfaro Lt 4 & Panamericana Norte , Quito, Pichincha ECUADOR verified
- Date published
- 06/24/2024 verified
- Product code
- 31 K - - 99 Tea, N.E.C. | 31 K - - 99 Tea, N.E.C. | 31 K - - 99 Tea, N.E.C. | 31 K - - 99 Tea, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 31 N - - 99 Novelty Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 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
- Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Plantain Grain (Llanten) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Plantain Grain (Llanten) | Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Plantain Grain (Llanten) | Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) | Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) | Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) | Sol Andino Naturally Healthy; Plantain Grain (Llanten) each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). | The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)). each item verified
What the source says
Pablo Francisco Beltran Sanchez Date Published : 06/24/2024 Eloy Alfaro Lt 4 & Panamericana Norte , Quito, Pichincha ECUADOR 31 K - - 99 Tea, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 31 K - - 99 Tea, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Plantain Grain (Llanten) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)). 31 K - - 99 Tea, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 31 K - - 99 Tea, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 31 N - - 99 Novelty Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 31 N - - 99 Novelty Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Plantain Grain (Llanten) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)). 31 N - - 99 Novelty Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 31 N - - 99 Novelty Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Plantain Grain (Llanten) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Melissa Leaf (Toronjil) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). “Toronjil” is translated in English to “Lemon Balm”. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Guava Leaf (Hoja de Guayaba) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Soursop Leaf (Hoja de Guanabana) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and the label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/24/2024 Desc: Sol Andino Naturally Healthy; Plantain Grain (Llanten) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3), in that is appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. § 343(f)] in that the label bears a foreign language but not all the mandatory label information is provided in the foreign language as required by 21 CFR 101.15(c)(2), and its label does not meet the requirements in 21 CFR 101.15(a) for the prominence of required statements, the statement of identity in English (21 CFR 101.3(a)) and that the nutrition facts information is not as defined in 21 CFR 101.9. Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product label fails to bear the correct common or usual name as required by 21 CFR 101.3(b). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 for “__ servings per container” (101.9(d)(3)(i)); declaration of Calories, and footnote statement (21 CFR 101.9). Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such a claim for use of the nutrient content claim “high in calcium and vitamins” (21 CFR 101.54(b)). The term “high” may be used on the label of foods provided that the food contains 20 percent or more of the RDI or the DRV per Reference Amount Customarily Consumed. Declaration of the nutrient that is the subject of a nutrient content claim is required in the Nutrition Facts label (21 CFR 101.13(n)).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html