# PAU YUEN TONG & CO · 66-41 · SOUTH AFRICA — FDA import alert red lists: firms subject to detention without physical examination

For PAU YUEN TONG & CO · 66-41 · SOUTH AFRICA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is SOUTH AFRICA; product is The Brush; product code is 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 10/01/2024; address is 16 Okiep Street , Pretoria, Gauteng SOUTH AFRICA, verified against its source on 2026-09-16.

- **Firm:** PAU YUEN TONG & CO _(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:** SOUTH AFRICA _(verified: appears in the quote below)_
- **Address:** 16 Okiep Street , Pretoria, Gauteng SOUTH AFRICA _(verified: appears in the quote below)_
- **Date published:** 10/01/2024 _(verified: appears in the quote below)_
- **Product code:** 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: appears in the quote below)_
- **Product:** The Brush _(verified: appears in the quote below)_
- **FDA notes:** The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. 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)]. There is no FDA-approved application in effect for “THE BRUSH.” Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. _(verified: appears in the quote below)_

## What the source says

> PAU YUEN TONG & CO Date Published : 10/01/2024 16 Okiep Street , Pretoria, Gauteng SOUTH AFRICA 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/01/2024 Desc: The Brush Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. 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)]. There is no FDA-approved application in effect for “THE BRUSH.” Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(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/).