Siam Industries International Co. Ltd. · 66-41 · THAILAND
For Siam Industries International Co. Ltd. · 66-41 · THAILAND, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is THAILAND; product is Kwao Krua Kao (Pueraria Mirifica) | Kwao Krua Dang (Butea superba) | Kwao Krua Kao (Pueraria Mirifica) | Kwao Krua Dang (Butea superba); product code is 54 A - - 99 Vitamin, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C; date published is 12/13/2017; address is 23 , 555 Muban Thang Rot Fai Fang Tawan Tok Lane , Hua Hin, Prachuap Khiri Khan THAILAND, verified against its source on 2026-09-16.
- Firm
- Siam Industries International Co. Ltd. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- THAILAND verified
- Address
- 23 , 555 Muban Thang Rot Fai Fang Tawan Tok Lane , Hua Hin, Prachuap Khiri Khan THAILAND verified
- Date published
- 12/13/2017 verified
- Product code
- 54 A - - 99 Vitamin, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. each item verified
- Product
- Kwao Krua Kao (Pueraria Mirifica) | Kwao Krua Dang (Butea superba) | Kwao Krua Kao (Pueraria Mirifica) | Kwao Krua Dang (Butea superba) each item verified
- FDA notes
- Problem(s): "Kwao Krua Kao (Pueraria Mirifica)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Kao (Pueraria Mirifica)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Kao (Pueraria Mirifica)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Kao (Pueraria Mirifica)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Kao (Pueraria Mirifica)" to appear to be misbranded under section 502(f)(1) of the FD&C Act. | Problem(s): "Kwao Krua Dang (Butea superba)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Dang (Butea superba)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Dang (Butea superba)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Dang (Butea superba)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Dang (Butea superba)" to appear to be misbranded under section 502(f)(1) of the FD&C Act. | Problem(s): "Kwao Krua Kao (Pueraria Mirifica)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Kao (Pueraria Mirifica)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Kao (Pueraria Mirifica)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Kao (Pueraria Mirifica)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Kao (Pueraria Mirifica)" to appear to be misbranded under section 502(f)(1) of the FD&C Act. | Problem(s): "Kwao Krua Dang (Butea superba)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Dang (Butea superba)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Dang (Butea superba)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Dang (Butea superba)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Dang (Butea superba)" to appear to be misbranded under section 502(f)(1) of the FD&C Act. each item verified
What the source says
Siam Industries International Co. Ltd. Date Published : 12/13/2017 23 , 555 Muban Thang Rot Fai Fang Tawan Tok Lane , Hua Hin, Prachuap Khiri Khan THAILAND 54 A - - 99 Vitamin, N.E.C. Date Published: 12/13/2017 Desc: Kwao Krua Kao (Pueraria Mirifica) Notes: Problem(s): "Kwao Krua Kao (Pueraria Mirifica)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Kao (Pueraria Mirifica)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Kao (Pueraria Mirifica)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Kao (Pueraria Mirifica)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Kao (Pueraria Mirifica)" to appear to be misbranded under section 502(f)(1) of the FD&C Act. 54 A - - 99 Vitamin, N.E.C. Date Published: 12/13/2017 Desc: Kwao Krua Dang (Butea superba) Notes: Problem(s): "Kwao Krua Dang (Butea superba)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Dang (Butea superba)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Dang (Butea superba)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Dang (Butea superba)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Dang (Butea superba)" to appear to be misbranded under section 502(f)(1) of the FD&C Act. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 12/13/2017 Desc: Kwao Krua Kao (Pueraria Mirifica) Notes: Problem(s): "Kwao Krua Kao (Pueraria Mirifica)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Kao (Pueraria Mirifica)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Kao (Pueraria Mirifica)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Kao (Pueraria Mirifica)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Kao (Pueraria Mirifica)" to appear to be misbranded under section 502(f)(1) of the FD&C Act. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 12/13/2017 Desc: Kwao Krua Dang (Butea superba) Notes: Problem(s): "Kwao Krua Dang (Butea superba)" appears to be a drug as defined by section 201(g)(1) of the FD&C Act because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of man. "Kwao Krua Dang (Butea superba)" also appears to be a new drug as defined by section 201(p) of the FD&C Act because we are not aware of evidence demonstrating that it is generally recognized as safe and effective for its labeled uses. A new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA approved new drug application. "Kwao Krua Dang (Butea superba)" is not the subject of such an application; therefore, it appears to be in violation of section 505(a) of the FD&C Act. Additionally, the product labeling for "Kwao Krua Dang (Butea superba)" fails to bear adequate directions for its intended uses, causing "Kwao Krua Dang (Butea superba)" to appear to be misbranded under section 502(f)(1) of the FD&C Act.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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