BIO PORT KOREA,INC. · 66-41 · KOREA (THE REPUBLIC OF) (#304 Marine Biotechnology Center San1-1 , Gwaebop-Dong , Sasang-Gu, PUSAN KOREA (THE REPUBLIC OF))
For BIO PORT KOREA,INC. (#304 Marine Biotechnology Center San1-1 , Gwaebop-Dong , Sasang-Gu, PUSAN KOREA (THE REPUBLIC OF)), import alert is 66-41; country is KOREA (THE REPUBLIC OF); import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Pine Needle Extract | Pine Needle Extract | Pine Needle Extract | Pine Needle Extract; product code is 54 D - - -- Unconv Diet Spec (No Vit/Min Stmt) | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/08/2015; address is #304 Marine Biotechnology Center San1-1 , Gwaebop-Dong , Sasang-Gu, PUSAN KOREA (THE REPUBLIC OF), verified against its source on 2026-10-01.
- Firm
- BIO PORT KOREA,INC. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- #304 Marine Biotechnology Center San1-1 , Gwaebop-Dong , Sasang-Gu, PUSAN KOREA (THE REPUBLIC OF) verified
- Date published
- 06/08/2015 verified
- Product code
- 54 D - - -- Unconv Diet Spec (No Vit/Min Stmt) | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Pine Needle Extract | Pine Needle Extract | Pine Needle Extract | Pine Needle Extract each item verified
- FDA notes
- The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". | The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". | The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". ; | The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". ; each item verified
What the source says
BIO PORT KOREA,INC. Date Published : 06/08/2015 #304 Marine Biotechnology Center San1-1 , Gwaebop-Dong , Sasang-Gu, PUSAN KOREA (THE REPUBLIC OF)
— 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 D - - -- Unconv Diet Spec (No Vit/Min Stmt) Date Published: 06/08/2015 Desc: Pine Needle Extract Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 06/08/2015 Desc: Pine Needle Extract Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 06/08/2015 Desc: Pine Needle Extract Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". ; 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/08/2015 Desc: Pine Needle Extract Notes: The above-listed product appears to be an unapproved new drug as the product website; www.qrapha.com; implies the product is intended for use in the diagnosis; cure; mitigation; treatment; or prevention of disease. Examples of claims on the website include; but are not limited to the following; "[P]ine needle helps to control gout; high blood pressure; prevents stroke..."; "Pine needle...control blood pressure; and reduce blood clots."; and "Silla University Food Chemistry Lab; Oct. 2006 had conducted in vivo testing that for six weeks Pine Needle extract supplemented at 100mg/kg bw/day to Sprague-Dawley; ovariectomized rats induced high cholesterol. The results stated that their total cholesterol...have decreased...". ;
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html