SANSHOKAKEN K.K. · 66-41 · JAPAN
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
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- JAPAN verified
- Address
- 1 Chome 7-25 , Sugimoto; Sumiyoshi , Osaka, Osaka JAPAN verified
- Date published
- 11/05/2019 verified
- Product code
- 53 L - - 99 Other Skin Care Preparations, N.E.C. verified
- Product
- Sanaderm Anti-Aging Serum verified
- 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
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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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