# Karen Laboratorio, S.A. de C.V. · 66-41 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For Karen Laboratorio, S.A. de C.V. · 66-41 · MEXICO, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is MEXICO; product is DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System; product code is 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 A - - 99 Vitamin, 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; date published is 04/13/2020; address is Avenida Rio Chiquito No. 2 , Texcoco , Pueblo San Simon, Mexico MEXICO, verified against its source on 2026-09-16.

- **Firm:** Karen Laboratorio, S.A. de C.V. _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** MEXICO _(verified: appears in the quote below)_
- **Address:** Avenida Rio Chiquito No. 2 , Texcoco , Pueblo San Simon, Mexico MEXICO _(verified: appears in the quote below)_
- **Date published:** 04/13/2020 _(verified: appears in the quote below)_
- **Product code:** 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 A - - 99 Vitamin, 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. _(verified: each item appears in the quote below)_
- **Product:** DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System | DITOXIFY Whole Body Detox System _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. _(verified: each item appears in the quote below)_

## What the source says

> Karen Laboratorio, S.A. de C.V. Date Published : 04/13/2020 Avenida Rio Chiquito No. 2 , Texcoco , Pueblo San Simon, Mexico MEXICO 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) Date Published: 04/13/2020 Desc: DITOXIFY Whole Body Detox System Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 04/13/2020 Desc: DITOXIFY Whole Body Detox System Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 54 A - - 99 Vitamin, N.E.C. Date Published: 04/13/2020 Desc: DITOXIFY Whole Body Detox System Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/13/2020 Desc: DITOXIFY Whole Body Detox System Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/13/2020 Desc: DITOXIFY Whole Body Detox System Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and its labeling bears claim for is intended for use as a drug. Example of this claim from the product labeling includes: "Eliminates toxins and parasites from digestive, urinary, lymphatic, and hepatic systems of your body for a true whole body detox". The product appears to be a new drug, as per Section 201(p) of the Act [21 U.S.C. § 321(p)], and is not generally recognized as safe and effective for the intended uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval. The violative product was transmitted to FDA as "Food Supplement"; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.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/).