Rohto Pharmaceutical Co., Ltd. · 66-41 · JAPAN
For Rohto Pharmaceutical Co., Ltd., import alert is 66-41; country is JAPAN; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- Firm
- Rohto Pharmaceutical Co., Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- JAPAN verified
- Address
- Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN verified
- Date published
- 07/17/2025 verified
- Product code
- 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Melano CC Brightening Milk | Melano CC Brightening Milk each item verified
- 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)]. each item verified
What the source says
Rohto Pharmaceutical Co., Ltd. Date Published : 07/17/2025 Rotoseiyaku (Kabu) , 1 Chome 8-1; Tatsuminishi; Ikuno , Osaka, Osaka JAPAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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)].
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html