Reference Source

BIO PORT KOREA,INC. · 66-41 · KOREA (THE REPUBLIC OF)

For BIO PORT KOREA,INC. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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) 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...". ;

accessdata.fda.gov, retrieved 2026-09-15

Source

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