# Bionutricia Manufacturing SDN BHD · 66-41 · MALAYSIA — FDA import alert red lists: firms subject to detention without physical examination

For Bionutricia Manufacturing SDN BHD · 66-41 · MALAYSIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is MALAYSIA; product is Longjack Extract Ekstract Tongkat Ali; product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 10/10/2024; address is No. 37, 39, 41 Jalan Tsb 1 , Taman Perindustrian Sungai Buloh , Sungai Buloh, Selangor MALAYSIA, verified against its source on 2026-09-16.

- **Firm:** Bionutricia Manufacturing SDN BHD _(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:** MALAYSIA _(verified: appears in the quote below)_
- **Address:** No. 37, 39, 41 Jalan Tsb 1 , Taman Perindustrian Sungai Buloh , Sungai Buloh, Selangor MALAYSIA _(verified: appears in the quote below)_
- **Date published:** 10/10/2024 _(verified: appears in the quote below)_
- **Product code:** 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. _(verified: appears in the quote below)_
- **Product:** Longjack Extract Ekstract Tongkat Ali _(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)]. 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

> Bionutricia Manufacturing SDN BHD Date Published : 10/10/2024 No. 37, 39, 41 Jalan Tsb 1 , Taman Perindustrian Sungai Buloh , Sungai Buloh, Selangor MALAYSIA 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/10/2024 Desc: Longjack Extract Ekstract Tongkat Ali 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)]. 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/).