# SESDERMA SL · 66-41 · SPAIN — FDA import alert red lists: firms subject to detention without physical examination

For SESDERMA SL · 66-41 · SPAIN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SPAIN; product is Mediderma Exoses LB Vitalizing | Meso Cit Timp-2 | Melaspeel K | Sucses Peel Step 2 | Mediderma Exoses LB Vitalizing | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing | Sucses Peel Step 2 | Melaspeel K | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing | Sucses Peel Step 2 | Mediderma Exoses LB Vitalizing | Sucses Peel Step 2 | Melaspeel K | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing; product code is 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 01/31/2025; address is Pol Industrial La Murta , Avinguda Molins 12 , Pucol, Valencia SPAIN, verified against its source on 2026-09-16.

- **Firm:** SESDERMA SL _(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:** SPAIN _(verified: appears in the quote below)_
- **Address:** Pol Industrial La Murta , Avinguda Molins 12 , Pucol, Valencia SPAIN _(verified: appears in the quote below)_
- **Date published:** 01/31/2025 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Mediderma Exoses LB Vitalizing | Meso Cit Timp-2 | Melaspeel K | Sucses Peel Step 2 | Mediderma Exoses LB Vitalizing | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing | Sucses Peel Step 2 | Melaspeel K | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing | Sucses Peel Step 2 | Mediderma Exoses LB Vitalizing | Sucses Peel Step 2 | Melaspeel K | Meso Cit Timp-2 | Mediderma Exoses LB Vitalizing _(verified: each item appears in the quote below)_
- **FDA notes:** The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. | The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. _(verified: each item appears in the quote below)_

## What the source says

> SESDERMA SL Date Published : 01/31/2025 Pol Industrial La Murta , Avinguda Molins 12 , Pucol, Valencia SPAIN 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Melaspeel K Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/31/2025 Desc: Melaspeel K Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Sucses Peel Step 2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Melaspeel K Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Meso Cit Timp-2 Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/31/2025 Desc: Mediderma Exoses LB Vitalizing Notes: The product is not generally recognized as safe and effective for the described uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)] based on statements in product labeling that provide evidence of the intended uses. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].

## 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/).