Bionutricia Manufacturing SDN BHD · 66-41 · MALAYSIA
For Bionutricia Manufacturing SDN BHD, import alert is 66-41; country is MALAYSIA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; 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 2026-10-01.
- Firm
- Bionutricia Manufacturing SDN BHD verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- MALAYSIA verified
- Address
- No. 37, 39, 41 Jalan Tsb 1 , Taman Perindustrian Sungai Buloh , Sungai Buloh, Selangor MALAYSIA verified
- Date published
- 10/10/2024 verified
- Product code
- 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. verified
- Product
- Longjack Extract Ekstract Tongkat Ali verified
- 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
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
— 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
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)].
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html