Marudhar Impex · 99-39 · INDIA

For Marudhar Impex · 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 Berberine Capsules | Berberine Capsules | Berberine Capsules | Apple Cider Vinegar Powder | Jamun Seed Powder | Miniature Papaya Leaf Powder | Papaya Leaf Powder/Aloe Vera Powder/Cascara Sagrada Extract Capsules | Papaya Leaf Powder | Berberine Capsules | Soursop Capsules | Soursop Capsules | Sea Moss Capsules | Fenugreek Organic Powder | Berberine Capsules | Berberine Capsules | Lemongrass Organic Powder | Asafoetida Powder | Black Seed Capsules | Black Seed Oil Capsules | Black Seed Oil Capsules | Moringa Turmeric Ginger w/Black Pepper Capsules | Black Seed Capsules | Ashwagandha Capsules | Moringa Capsules | Miniature Papaya Leaf Powder | Black Seed Capsules | Ashwagandha Capsules | Moringa Capsules | Saw Palmetto Capsules | Milk Thistle Extract Capsules | Papaya Leaf Powder | Triphala Capsules | Berberine Capsules | Aloe Vera Organic Powder | Lemongrass Organic Powder | Gotukola Organic Powder | Shilajit Extract Capsules | Black Seed Oil Capsules | Brahmi Organic Powder | Magnesium L-threonate Capsules | Papaya Leaf Powder/Aloe Vera Powder/Cascara Sagrada Extract Capsules | Sea Moss Capsules | Gymnema Organic Powder | Acacia Gum Powder | Kalmegh Powder | Neem Organic Powder | Asafoetida Powder | Fenugreek Organic Powder | Aloe Vera Gel Powder 200x | Guduchi Organic Powder | Punarnava Powder | Hibiscus Organic Powder | Apple Cider Vinegar Powder | Jamun Seed Powder | Manjistha Organic Powder | Amla Organic Powder | Black Seed Capsules | Magnesium L-threonate Capsules | Milk Thistle Extract Capsules | Milk Thistle Extract Capsules | Milk Thistle Extract Capsules | Black Seed Capsules | Nopal Capsules | Black Seed Capsules | Aloe Vera Gel Powder 200x | Moringa Capsules | Sea Moss Capsules | Berberine Capsules | Guduchi Organic Powder | Ashwagandha Capsules | Black Seed Oil Capsules | Lemongrass Organic Powder | Neem Organic Powder | Hibiscus Organic Powder | Aloe Vera Organic Powder | Papaya Leaf Powder | Apple Cider Vinegar Powder | Saw Palmetto Capsules | Brahmi Organic Powder | Fenugreek Organic Powder | Papaya Leaf Powder/Aloe Vera Powder/Cascara Sagrada Extract Capsules | Amla Organic Powder | Magnesium L-threonate Capsules | Shilajit Extract Capsules | Punarnava Powder | Manjistha Organic Powder | Triphala Capsules | Asafoetida Powder | Moringa Turmeric Ginger w/Black Pepper Capsules | Miniature Papaya Leaf Powder | Gymnema Organic Powder | Triphala Capsules; product code is 14 Y - - 99 Filled or Imitation Milk or Milk Type Products Not Elsewhere Mentioned, N.E.C. | 20 B - - 07 Elderberries, Dried or Paste | 20 B - - 21 Barberry, Dried or Paste | 20 S - - 01 Apple, Core Fruit Juices or Concentrates | 21 H - - 14 Plum, Dried or Paste | 21 M - - 06 Vine Fruit Flavored Imitation Fruit | 21 M - - 06 Vine Fruit Flavored Imitation Fruit | 21 M - - 06 Vine Fruit Flavored Imitation Fruit | 22 B - - 05 Bitter Melon, Dried or Paste | 22 G - - 04 Soursop (Other Fruit Products) | 22 H - - 04 Soursop, Dried or Paste | 24 U - - 29 Seaweed, Dried or Paste | 28 A - - 56 Fenugreek, Whole (Spice) | 28 C - - 13 Cinnamon, Cassia, Natural Extract or Flavor (Spice) | 28 C - - 49 Turmeric, Natural Extract or Flavor (Spice) | 28 C - - 57 Lemon Grass, Natural Extract or Flavor (Spice) | 28 C - - 66 Asafetida, Natural Extract or Flavor (Spice) | 28 C - - 67 Black Cumin, Natural Extract or Flavor (Spice) | 28 C - - 67 Black Cumin, Natural Extract or Flavor (Spice) | 28 C - - 99 Natural Extract or Flavor, N.E.C. | 28 C - - 99 Natural Extract or Flavor, N.E.C. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 41 - - - -- Dietary Conv Food/Meal Replacements | 54 B - - 07 Iron (Mineral) | 54 B - - 08 Magnesium (Mineral) | 54 E - - 84 Milk Thistle | 54 F - - 84 Milk Thistle (Herbal & Botanical other than teas) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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; date published is 08/21/2024; address is B/36 Sumel Business Park 5 , Ahmedabad, Gujarat INDIA, verified against its source on 2026-09-16.

What the source says

Marudhar Impex Date Published : 08/21/2024 B/36 Sumel Business Park 5 , Ahmedabad, Gujarat INDIA 14 Y - - 99 Filled or Imitation Milk or Milk Type Products Not Elsewhere Mentioned, N.E.C. Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 20 B - - 07 Elderberries, Dried or Paste Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 20 B - - 21 Barberry, Dried or Paste Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 20 S - - 01 Apple, Core Fruit Juices or Concentrates Date Published: 08/21/2024 Desc: Apple Cider Vinegar Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 21 H - - 14 Plum, Dried or Paste Date Published: 08/21/2024 Desc: Jamun Seed Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. 21 M - - 06 Vine Fruit Flavored Imitation Fruit Date Published: 08/21/2024 Desc: Miniature Papaya Leaf Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. 21 M - - 06 Vine Fruit Flavored Imitation Fruit Date Published: 08/21/2024 Desc: Papaya Leaf Powder/Aloe Vera Powder/Cascara Sagrada Extract 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 21 M - - 06 Vine Fruit Flavored Imitation Fruit Date Published: 08/21/2024 Desc: Papaya Leaf Powder 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 in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 22 B - - 05 Bitter Melon, Dried or Paste Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 22 G - - 04 Soursop (Other Fruit Products) Date Published: 08/21/2024 Desc: Soursop 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 22 H - - 04 Soursop, Dried or Paste Date Published: 08/21/2024 Desc: Soursop 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 24 U - - 29 Seaweed, Dried or Paste Date Published: 08/21/2024 Desc: Sea Moss 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(e)(2) of the Act in that the Label fails to declare the net quantity of contents. Labels must declare on the principal display panel the net contents in U.S. Customary System (fluid ounces, pounds) and in most cases metric (milliliters, liters) terms. The metric statement may be placed either before or after the U. S. Customary statement, or above or below it (21 CFR 101.7). Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 28 A - - 56 Fenugreek, Whole (Spice) Date Published: 08/21/2024 Desc: Fenugreek Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 28 C - - 13 Cinnamon, Cassia, Natural Extract or Flavor (Spice) Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 28 C - - 49 Turmeric, Natural Extract or Flavor (Spice) Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 28 C - - 57 Lemon Grass, Natural Extract or Flavor (Spice) Date Published: 08/21/2024 Desc: Lemongrass Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 28 C - - 66 Asafetida, Natural Extract or Flavor (Spice) Date Published: 08/21/2024 Desc: Asafoetida Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 28 C - - 67 Black Cumin, Natural Extract or Flavor (Spice) Date Published: 08/21/2024 Desc: Black Seed 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 28 C - - 67 Black Cumin, Natural Extract or Flavor (Spice) Date Published: 08/21/2024 Desc: Black Seed Oil 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 28 C - - 99 Natural Extract or Flavor, N.E.C. Date Published: 08/21/2024 Desc: Black Seed Oil 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 28 C - - 99 Natural Extract or Flavor, N.E.C. Date Published: 08/21/2024 Desc: Moringa Turmeric Ginger w/Black Pepper 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 08/21/2024 Desc: Black Seed 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 08/21/2024 Desc: Ashwagandha 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 08/21/2024 Desc: Moringa 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 08/21/2024 Desc: Miniature Papaya Leaf Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 08/21/2024 Desc: Black Seed 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 08/21/2024 Desc: Ashwagandha 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 08/21/2024 Desc: Moringa 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 08/21/2024 Desc: Saw Palmetto 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 08/21/2024 Desc: Milk Thistle Extract 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 08/21/2024 Desc: Papaya Leaf Powder 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 in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Triphala 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Aloe Vera Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Lemongrass Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Gotukola Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Shilajit Extract 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Black Seed Oil 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Brahmi Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Magnesium L-threonate 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Papaya Leaf Powder/Aloe Vera Powder/Cascara Sagrada Extract 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Sea Moss 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(e)(2) of the Act in that the Label fails to declare the net quantity of contents. Labels must declare on the principal display panel the net contents in U.S. Customary System (fluid ounces, pounds) and in most cases metric (milliliters, liters) terms. The metric statement may be placed either before or after the U. S. Customary statement, or above or below it (21 CFR 101.7). Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Gymnema Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Acacia Gum Powder 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 in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Kalmegh Powder 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 in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Neem Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Asafoetida Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Fenugreek Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Aloe Vera Gel Powder 200x 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Guduchi Organic Powder 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 in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Punarnava Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Hibiscus Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Apple Cider Vinegar Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Jamun Seed Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Manjistha Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 41 - - - -- Dietary Conv Food/Meal Replacements Date Published: 08/21/2024 Desc: Amla Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 B - - 07 Iron (Mineral) Date Published: 08/21/2024 Desc: Black Seed 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 54 B - - 08 Magnesium (Mineral) Date Published: 08/21/2024 Desc: Magnesium L-threonate 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. 54 E - - 84 Milk Thistle Date Published: 08/21/2024 Desc: Milk Thistle Extract 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 F - - 84 Milk Thistle (Herbal & Botanical other than teas) Date Published: 08/21/2024 Desc: Milk Thistle Extract 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 08/21/2024 Desc: Milk Thistle Extract 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 08/21/2024 Desc: Black Seed 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 08/21/2024 Desc: Nopal 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/21/2024 Desc: Black Seed 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Aloe Vera Gel Powder 200x 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Moringa 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Sea Moss 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(e)(2) of the Act in that the Label fails to declare the net quantity of contents. Labels must declare on the principal display panel the net contents in U.S. Customary System (fluid ounces, pounds) and in most cases metric (milliliters, liters) terms. The metric statement may be placed either before or after the U. S. Customary statement, or above or below it (21 CFR 101.7). Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Berberine 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Guduchi Organic Powder 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 in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Ashwagandha 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Black Seed Oil 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Lemongrass Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Neem Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Hibiscus Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Aloe Vera Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Papaya Leaf Powder 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 in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Apple Cider Vinegar Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Saw Palmetto 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Brahmi Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Fenugreek Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Papaya Leaf Powder/Aloe Vera Powder/Cascara Sagrada Extract 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Amla Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Magnesium L-threonate 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Shilajit Extract 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Punarnava Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Manjistha Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Triphala 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Asafoetida Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Moringa Turmeric Ginger w/Black Pepper 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Miniature Papaya Leaf Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/21/2024 Desc: Gymnema Organic Powder 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 in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/21/2024 Desc: Triphala 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(q) of the Act in that the product appears to be misbranded in that the label or labeling fails to bear the required nutrition information. Section 403(y) of the Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act in that the label fails to list the name and place of business of the manufacturer, packer, or distributor. Section 403(r)(1)(A) of the Act. Product labeling does not meet the requirements to bear nutrient claims (21 CFR 101.54(b), (c), (e), (g), and (n)). The nutrient content requirements state, in part, that for a product to bear a “high”, “rich in”, or “excellent source of” claim, an RDI (Reference Daily Intake) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(b) and (c)]. RDI must be 20% or more; however, the products do not list the nutrients in the nutrition information or lists them in amounts that are 20% or more of the RDI. Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). If the entire or whole plant is used, then that information must be declared.

— accessdata.fda.gov, retrieved 2026-09-15

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• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.