# O'will Corporation · 66-41 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For O'will Corporation · 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 code is 53 - - - -- Cosmetics | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 09/30/2009; address is 2 Chome 13-12 , Hirakawa-Cho , Chiyoda, Tokyo JAPAN, verified against its source on 2026-09-16.

- **Firm:** O'will Corporation _(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:** 2 Chome 13-12 , Hirakawa-Cho , Chiyoda, Tokyo JAPAN _(verified: appears in the quote below)_
- **Date published:** 09/30/2009 _(verified: appears in the quote below)_
- **Product code:** 53 - - - -- Cosmetics | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **FDA notes:** 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications. | 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications. _(verified: each item appears in the quote below)_

## What the source says

> O'will Corporation Date Published : 09/30/2009 2 Chome 13-12 , Hirakawa-Cho , Chiyoda, Tokyo JAPAN 53 - - - -- Cosmetics Date Published: 09/30/2009 Notes: 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 09/30/2009 Notes: 12/5/2007. Nivea Goodbye. Product has been previously submitted for import misdeclared and product coded 53LF 06 as a moisturizing cosmetic. The product labeling states "continuous release one of it ingrediants into the fatty tissue of the skin." The OTC Monograph system does not include timed release or sustained release drug products, a dosage form that is designed to release the ingrediants over a prolonged period of time. All products in timed release dosage form are new drugs requiring approved applications.

## 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/).