# SANSHOKAKEN K.K. · 66-41 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For SANSHOKAKEN K.K. · 66-41 · JAPAN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is JAPAN; product is Sanaderm Anti-Aging Serum; product code is 53 L - - 99 Other Skin Care Preparations, N.E.C; date published is 11/05/2019; address is 1 Chome 7-25 , Sugimoto; Sumiyoshi , Osaka, Osaka JAPAN, verified against its source on 2026-09-16.

- **Firm:** SANSHOKAKEN K.K. _(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:** JAPAN _(verified: appears in the quote below)_
- **Address:** 1 Chome 7-25 , Sugimoto; Sumiyoshi , Osaka, Osaka JAPAN _(verified: appears in the quote below)_
- **Date published:** 11/05/2019 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 99 Other Skin Care Preparations, N.E.C. _(verified: appears in the quote below)_
- **Product:** Sanaderm Anti-Aging Serum _(verified: appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a), because it is intended to prevent, treat or cure disease conditions, and/or affect the structure or function of the body. Examples of claims observed on the firm's website, which identified product's label documenting the intended use of the product. These claims include, but are not limited to the following: "Prevent oxidation . . . whiten, and firm your skin. . ..". The product also appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling. _(verified: appears in the quote below)_

## What the source says

> SANSHOKAKEN K.K. Date Published : 11/05/2019 1 Chome 7-25 , Sugimoto; Sumiyoshi , Osaka, Osaka JAPAN 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 11/05/2019 Desc: Sanaderm Anti-Aging Serum Notes: The product appears to be an unapproved new drug in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a), because it is intended to prevent, treat or cure disease conditions, and/or affect the structure or function of the body. Examples of claims observed on the firm's website, which identified product's label documenting the intended use of the product. These claims include, but are not limited to the following: "Prevent oxidation . . . whiten, and firm your skin. . ..". The product also appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling.

## 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/).