Bionutricia Manufacturing SDN BHD · 66-41 · MALAYSIA
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
- 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 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)].
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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