FALCON SYSTEM OF AYURVEDIC PRODUCTS · 99-39 · INDIA

Product code, Product and FDA notes

41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Zaarah Herbals Sugset 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(q) of the Act. Label does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. “Servings Per Container” does not appear under “Serving Size,” which is not per 21 CFR 101.36(b)(1)(ii). Serving size in Supplement Facts label is not declared per by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures per in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Label fails to use “dietary supplement” on principal display panel, except “dietary” may be replaced by name of dietary ingredients in product or an appropriately descriptive term indicating type of dietary ingredients in product [21 CFR 101.3(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify part of plant from which each botanical dietary ingredient in product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) of the Act. Label fails to bear a domestic address or phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Shatavari Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that the 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Dashmool Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Label does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. The subheading “Servings Per Container” does not appear under the subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). The serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b) and must be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams). Section 403(s)(2)(B) of the Act in that the 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Triphala Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling of the products does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under the subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Vasaka Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Avipattikar Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Jamun Seed Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Rasayan Churan Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Licorice Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Tulsi Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Gurmar Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Haritaki Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Karela Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Dudhi Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Moringa Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 04/23/2025 Desc: Giloy Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Zaarah Herbals Sugset 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(q) of the Act. Label does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. “Servings Per Container” does not appear under “Serving Size,” which is not per 21 CFR 101.36(b)(1)(ii). Serving size in Supplement Facts label is not declared per by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures per in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Label fails to use “dietary supplement” on principal display panel, except “dietary” may be replaced by name of dietary ingredients in product or an appropriately descriptive term indicating type of dietary ingredients in product [21 CFR 101.3(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify part of plant from which each botanical dietary ingredient in product is derived, as required by 21 CFR 101.4(h)(1). Section 403(y) of the Act. Label fails to bear a domestic address or phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Giloy Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Moringa Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Dudhi Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Karela Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Haritaki Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Gurmar Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Tulsi Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Licorice Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Rasayan Churan Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Jamun Seed Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Avipattikar Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Vasaka Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Triphala Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Labeling of the products does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. Subheading “Servings Per Container” does not appear under the subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). Serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b). Section 403(s)(2)(B) of the Act. Labels fails to use term “dietary supplement” on the principal display panel, except that the word “dietary” may be 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(a), (b), and (g)]. Section 403(s)(2)(C) of the Act. Label fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Dashmool Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act. Label does not comply with 21 CFR 101.36, 21 CFR 101.7, and 21 CFR 101.9. The subheading “Servings Per Container” does not appear under the subheading “Serving Size,” which is not in accordance with 21 CFR 101.36(b)(1)(ii). The serving size in the Supplement Facts label fails to be declared as required by 21 CFR 101.36(b)(1)(i). Serving size must be expressed in common household measures as set forth in 21 CFR 101.9(b) and must be followed by the equivalent metric quantity in parenthesis (fluids in milliliters and all other foods in grams). Section 403(s)(2)(B) of the Act in that the 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(a), (b), and (g)]. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 04/23/2025 Desc: Shatavari Powder Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that the 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(a), (b), and (g)].