# Rohto Pharmaceutical Co., Ltd. · 66-41 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For Rohto Pharmaceutical Co., Ltd. · 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 Melano CC Brightening Milk | Melano CC Brightening Milk; product code is 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 07/17/2025; address is Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN, verified against its source on 2026-09-16.

- **Firm:** Rohto Pharmaceutical Co., Ltd. _(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:** Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN _(verified: appears in the quote below)_
- **Date published:** 07/17/2025 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Melano CC Brightening Milk | Melano CC Brightening Milk _(verified: each item appears in the quote below)_
- **FDA notes:** Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. 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)]. | Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. 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

> Rohto Pharmaceutical Co., Ltd. Date Published : 07/17/2025 Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 07/17/2025 Desc: Melano CC Brightening Milk Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. 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: 07/17/2025 Desc: Melano CC Brightening Milk Notes: Product appears to be unapproved new drug in violation of section 505(a) of the FD&C Act. 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/).