Planet Ayurveda Private Limited · 99-39 · INDIA
For Planet Ayurveda Private 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 Calm Easy capsules | Nature-Amino powder blend | Digestion Support | Calm Easy capsules | Digestion Support | Nature-Amino powder blend | Digestion Support | Nature-Amino powder blend | Calm Easy capsules; product code is 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/05/2025; address is Plot No - 627 Sector 82 - Mohali , Planet Ayurveda , Sas Nagar (Mohali), Punjab INDIA, verified against its source on 2026-09-16.
- Firm
- Planet Ayurveda Private 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
- Plot No - 627 Sector 82 - Mohali , Planet Ayurveda , Sas Nagar (Mohali), Punjab INDIA verified
- Date published
- 06/05/2025 verified
- Product code
- 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 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
- Calm Easy capsules | Nature-Amino powder blend | Digestion Support | Calm Easy capsules | Digestion Support | Nature-Amino powder blend | Digestion Support | Nature-Amino powder blend | Calm Easy capsules 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(q)(5)(F) of the Act. Supplement facts label is not formatted, as required by 21 CFR 101.36. Label fails to declare the amount of dietary ingredients beneath the heading “Amount Per Serving.” Label fails to have heavy bars placed where required. Section 403(f) of the Act. Label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(e)(1) of the Act. Name and place of business of the manufacturer, packer, or distributor is not placed on the information panel (21 CFR 101.2(b)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(q)(5)(F) of the Act. Supplement facts label is not formatted, as required by 21 CFR 101.36. Label fails to declare the amount of dietary ingredients beneath the heading “Amount Per Serving.” Label fails to have heavy bars placed where required. Section 403(f) of the Act. Label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(e)(1) of the Act. Name and place of business of the manufacturer, packer, or distributor is not placed on the information panel (21 CFR 101.2(b)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(q)(5)(F) of the Act. Supplement facts label is not formatted, as required by 21 CFR 101.36. Label fails to declare the amount of dietary ingredients beneath the heading “Amount Per Serving.” Label fails to have heavy bars placed where required. Section 403(f) of the Act. Label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(e)(1) of the Act. Name and place of business of the manufacturer, packer, or distributor is not placed on the information panel (21 CFR 101.2(b)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. | 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. each item verified
What the source says
Planet Ayurveda Private Limited Date Published : 06/05/2025 Plot No - 627 Sector 82 - Mohali , Planet Ayurveda , Sas Nagar (Mohali), Punjab INDIA 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 06/05/2025 Desc: Calm Easy capsules 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 06/05/2025 Desc: Nature-Amino powder blend 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(q)(5)(F) of the Act. Supplement facts label is not formatted, as required by 21 CFR 101.36. Label fails to declare the amount of dietary ingredients beneath the heading “Amount Per Serving.” Label fails to have heavy bars placed where required. Section 403(f) of the Act. Label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(e)(1) of the Act. Name and place of business of the manufacturer, packer, or distributor is not placed on the information panel (21 CFR 101.2(b)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 06/05/2025 Desc: Digestion Support 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 06/05/2025 Desc: Calm Easy capsules 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 06/05/2025 Desc: Digestion Support 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 06/05/2025 Desc: Nature-Amino powder blend 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(q)(5)(F) of the Act. Supplement facts label is not formatted, as required by 21 CFR 101.36. Label fails to declare the amount of dietary ingredients beneath the heading “Amount Per Serving.” Label fails to have heavy bars placed where required. Section 403(f) of the Act. Label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(e)(1) of the Act. Name and place of business of the manufacturer, packer, or distributor is not placed on the information panel (21 CFR 101.2(b)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/05/2025 Desc: Digestion Support 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/05/2025 Desc: Nature-Amino powder blend 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Section 403(q)(5)(F) of the Act. Supplement facts label is not formatted, as required by 21 CFR 101.36. Label fails to declare the amount of dietary ingredients beneath the heading “Amount Per Serving.” Label fails to have heavy bars placed where required. Section 403(f) of the Act. Label contains information in two languages but does not repeat all the required information in both languages (21 CFR 101.15(c)), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. Section 403(e)(1) of the Act. Name and place of business of the manufacturer, packer, or distributor is not placed on the information panel (21 CFR 101.2(b)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/05/2025 Desc: Calm Easy capsules 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(s)(2)(B) of the Act. Labels fail to include the statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (21 CFR 101.3(g)). Section 403(q)(1)(A) of the Act. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use suggest the consumer take “1-2 capsules once or twice daily” but the serving size lists 1 capsule. The serving size listed should be two capsules. The “Serving size“, “Servings Per Container,” “Amount Per Serving,” and the quantitative amount by weight per serving size are incorrect. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant (e.g. root, leaves) form which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). Violation was noted based on an FDA inspection of the foreign food manufacturing facility from December 12, 2024 through January 22, 2025.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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