# LEJAL LAB INC. · 99-39 · PHILIPPINES — FDA import alert red lists: firms subject to detention without physical examination

For LEJAL LAB INC. · 99-39 · PHILIPPINES, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is PHILIPPINES; product is LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules; product code is 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 03/12/2020; address is MacArthur Highway , Meycauayan, Bulacan PHILIPPINES, verified against its source on 2026-09-16.

- **Firm:** LEJAL LAB 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:** PHILIPPINES _(verified: appears in the quote below)_
- **Address:** MacArthur Highway , Meycauayan, Bulacan PHILIPPINES _(verified: appears in the quote below)_
- **Date published:** 03/12/2020 _(verified: appears in the quote below)_
- **Product code:** 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs _(verified: each item appears in the quote below)_
- **Product:** LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules | LiverGuard Silymarin Lecithin Capsules _(verified: each item appears in the quote below)_
- **FDA notes:** The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. _(verified: each item appears in the quote below)_

## What the source says

> LEJAL LAB INC. Date Published : 03/12/2020 MacArthur Highway , Meycauayan, Bulacan PHILIPPINES 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 05/26/2022 60 - - - -- Human and Animal Drugs Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 61 - - - -- Human and Animal Drugs Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 62 - - - -- Human and Animal Drugs Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 63 - - - -- Human and Animal Drugs Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 64 - - - -- Human and Animal Drugs Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 65 - - - -- Human and Animal Drugs Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor. 66 - - - -- Human and Animal Drugs Date Published: 03/12/2020 Desc: LiverGuard Silymarin Lecithin Capsules Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(i)(2) of the FD&C Act, product is fabricated from two or more ingredients and the ingredients are not declared appropriately [21 CFR 101.4 and 21 CFR 101.36]. Blister pack does not meet the exemptions from required label statements under 21 CFR 1.24(a)(14). Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)), nutrition labeling does not comply with 21 CFR 101.36 - label is missing heading "Supplement Facts" as required by 21 CFR 101.36(b)(1)(i). Statement: "other dietary ingredients" - silymarin and lecithin - fail to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" (in lieu of "% RENI", a term that is not permitted within the Supplement Facts label) that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient listed. [21 CFR 101.36(b)(3)(iv)] Section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)], label of outer box and inner sleeves do not include statement of identity as "dietary supplement" or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(g)]. Section 403(y) of the Act [21 U.S.C. § 343(y)], label of outer box, inner sleeves, and each blister pack fails to bear responsible person contact info (as described in section 761) who may receive a report of a serious adverse event with such dietary supplement. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], blister pack label does not meet the exemptions from required label statements. Label of each unit container does not bear the name and place of business of the manufacturer, packer, or distributor.

## 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/).