# Mount Kailash Rejuvenation Centre Inc. · 99-39 · SAINT LUCIA — FDA import alert red lists: firms subject to detention without physical examination

For Mount Kailash Rejuvenation Centre Inc. · 99-39 · SAINT LUCIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is SAINT LUCIA; product is Herbal Intellectual Power Dietary Supplements | Seed Of Source Male Dietary Supplements | Seed Of Source Male Dietary Supplements | Herbal Intellectual Power Dietary Supplements | Herbal Intellectual Power Dietary Supplements | Seed Of Source Male Dietary Supplements; product code is 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human); date published is 03/12/2026; address is Marc, Bexon , Castries, Castries SAINT LUCIA, verified against its source on 2026-09-16.

- **Firm:** Mount Kailash Rejuvenation Centre Inc. _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** SAINT LUCIA _(verified: appears in the quote below)_
- **Address:** Marc, Bexon , Castries, Castries SAINT LUCIA _(verified: appears in the quote below)_
- **Date published:** 03/12/2026 _(verified: appears in the quote below)_
- **Product code:** 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - -- Herbal & Botanicals(other than teas) | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) _(verified: each item appears in the quote below)_
- **Product:** Herbal Intellectual Power Dietary Supplements | Seed Of Source Male Dietary Supplements | Seed Of Source Male Dietary Supplements | Herbal Intellectual Power Dietary Supplements | Herbal Intellectual Power Dietary Supplements | Seed Of Source Male Dietary Supplements _(verified: each item appears in the quote below)_
- **FDA notes:** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. For Finished Product: Section 403(s)(2)(B) of the Act. Label fails to include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition information on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients which is not in accordance with 21 CFR 101.36(b)(3)(i). A second statement of “Amount Per Serving” is incorrectly placed below the heading “Supplement Facts”. Missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). The statement “FREE OF: Heavy metals…” is placed within the Supplement Facts label, (21 CFR 101.2(d)) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i). Label fails to declare a complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). | 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act. Supplement contains an herb or other botanical described in section 201(ff)(1)(C), and label or labeling fails to identify any part of the plant from which the ingredient is derived. For Finished Product Only: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that it does not include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition facts on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients (21 CFR 101.36(b)(3)(i)). Label missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). Ingredients mssing a symbol (e.g., an asterisk) that refers to the same symbol placed at the bottom of the nutrition label and followed by “Daily Value not established” (21 CFR 101.36(b)(3)(iv)). “FREE OF: Heavy metals…” is placed within the Supplement Facts label, not in accordance with 21 CFR 101.2(d) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i)]. Missing complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). | 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act. Supplement contains an herb or other botanical described in section 201(ff)(1)(C), and label or labeling fails to identify any part of the plant from which the ingredient is derived. For Finished Product Only: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that it does not include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition facts on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients (21 CFR 101.36(b)(3)(i)). Label missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). Ingredients mssing a symbol (e.g., an asterisk) that refers to the same symbol placed at the bottom of the nutrition label and followed by “Daily Value not established” (21 CFR 101.36(b)(3)(iv)). “FREE OF: Heavy metals…” is placed within the Supplement Facts label, not in accordance with 21 CFR 101.2(d) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i)]. Missing complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). | 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. For Finished Product: Section 403(s)(2)(B) of the Act. Label fails to include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition information on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients which is not in accordance with 21 CFR 101.36(b)(3)(i). A second statement of “Amount Per Serving” is incorrectly placed below the heading “Supplement Facts”. Missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). The statement “FREE OF: Heavy metals…” is placed within the Supplement Facts label, (21 CFR 101.2(d)) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i). Label fails to declare a complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). | 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. For Finished Product: Section 403(s)(2)(B) of the Act. Label fails to include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition information on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients which is not in accordance with 21 CFR 101.36(b)(3)(i). A second statement of “Amount Per Serving” is incorrectly placed below the heading “Supplement Facts”. Missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). The statement “FREE OF: Heavy metals…” is placed within the Supplement Facts label, (21 CFR 101.2(d)) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i). Label fails to declare a complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). | 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act. Supplement contains an herb or other botanical described in section 201(ff)(1)(C), and label or labeling fails to identify any part of the plant from which the ingredient is derived. For Finished Product Only: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that it does not include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition facts on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients (21 CFR 101.36(b)(3)(i)). Label missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). Ingredients mssing a symbol (e.g., an asterisk) that refers to the same symbol placed at the bottom of the nutrition label and followed by “Daily Value not established” (21 CFR 101.36(b)(3)(iv)). “FREE OF: Heavy metals…” is placed within the Supplement Facts label, not in accordance with 21 CFR 101.2(d) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i)]. Missing complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). _(verified: each item appears in the quote below)_

## What the source says

> Mount Kailash Rejuvenation Centre Inc. Date Published : 03/12/2026 Marc, Bexon , Castries, Castries SAINT LUCIA 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 03/12/2026 Desc: Herbal Intellectual Power Dietary Supplements 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. For Finished Product: Section 403(s)(2)(B) of the Act. Label fails to include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition information on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients which is not in accordance with 21 CFR 101.36(b)(3)(i). A second statement of “Amount Per Serving” is incorrectly placed below the heading “Supplement Facts”. Missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). The statement “FREE OF: Heavy metals…” is placed within the Supplement Facts label, (21 CFR 101.2(d)) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i). Label fails to declare a complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 03/12/2026 Desc: Seed Of Source Male Dietary Supplements 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act. Supplement contains an herb or other botanical described in section 201(ff)(1)(C), and label or labeling fails to identify any part of the plant from which the ingredient is derived. For Finished Product Only: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that it does not include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition facts on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients (21 CFR 101.36(b)(3)(i)). Label missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). Ingredients mssing a symbol (e.g., an asterisk) that refers to the same symbol placed at the bottom of the nutrition label and followed by “Daily Value not established” (21 CFR 101.36(b)(3)(iv)). “FREE OF: Heavy metals…” is placed within the Supplement Facts label, not in accordance with 21 CFR 101.2(d) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i)]. Missing complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 03/12/2026 Desc: Seed Of Source Male Dietary Supplements 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act. Supplement contains an herb or other botanical described in section 201(ff)(1)(C), and label or labeling fails to identify any part of the plant from which the ingredient is derived. For Finished Product Only: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that it does not include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition facts on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients (21 CFR 101.36(b)(3)(i)). Label missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). Ingredients mssing a symbol (e.g., an asterisk) that refers to the same symbol placed at the bottom of the nutrition label and followed by “Daily Value not established” (21 CFR 101.36(b)(3)(iv)). “FREE OF: Heavy metals…” is placed within the Supplement Facts label, not in accordance with 21 CFR 101.2(d) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i)]. Missing complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 03/12/2026 Desc: Herbal Intellectual Power Dietary Supplements 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. For Finished Product: Section 403(s)(2)(B) of the Act. Label fails to include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition information on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients which is not in accordance with 21 CFR 101.36(b)(3)(i). A second statement of “Amount Per Serving” is incorrectly placed below the heading “Supplement Facts”. Missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). The statement “FREE OF: Heavy metals…” is placed within the Supplement Facts label, (21 CFR 101.2(d)) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i). Label fails to declare a complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 03/12/2026 Desc: Herbal Intellectual Power Dietary Supplements 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived. For Finished Product: Section 403(s)(2)(B) of the Act. Label fails to include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition information on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D)). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients which is not in accordance with 21 CFR 101.36(b)(3)(i). A second statement of “Amount Per Serving” is incorrectly placed below the heading “Supplement Facts”. Missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). The statement “FREE OF: Heavy metals…” is placed within the Supplement Facts label, (21 CFR 101.2(d)) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i). Label fails to declare a complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)). 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 03/12/2026 Desc: Seed Of Source Male Dietary Supplements 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: For Bulk and Finished Product: Section 403(s)(2)(C) of the FD&C Act. Supplement contains an herb or other botanical described in section 201(ff)(1)(C), and label or labeling fails to identify any part of the plant from which the ingredient is derived. For Finished Product Only: Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] in that it does not include a statement of identity as a “dietary supplement” or “herbal supplement” (21 CFR 101.3(g)). Section 403(y) of the Act. Missing domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. Sections 403(s)(2)(A)(ii) and 403(q)(5). Nutrition facts on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.2. “Daily Values Based on a 2,000 Calorie Diet” is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein (21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). This statement is also incorrectly worded. “Amount Per Serving” is incorrectly placed above the (b)(3)-dietary ingredients (21 CFR 101.36(b)(3)(i)). Label missing quantitative amount by weight per serving of each dietary ingredient (21 CFR 101.36(b)(3)(ii)). Ingredients mssing a symbol (e.g., an asterisk) that refers to the same symbol placed at the bottom of the nutrition label and followed by “Daily Value not established” (21 CFR 101.36(b)(3)(iv)). “FREE OF: Heavy metals…” is placed within the Supplement Facts label, not in accordance with 21 CFR 101.2(d) and is considered intervening material. Section 403(e)(1) of the FD&C Act. Label missing current name and place of business of the manufacturer, packer, or distributor (21 CFR 101.5). Section 403(e)(2) of the FD&C Act and section 1453(a)(3)(A)(i) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)(A)(i)]. Missing complete and accurate statement of the net quantity of contents on the principal display panel (21 CFR 101.7). Section 403(r) of the FD&C Act. Labeling makes structure function claims but fails to bear the required dietary supplement disclaimer (21 CFR 101.93(b)-(d)).

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).