Import Alert 66-71
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-71
Published Date: 08/11/2023
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Unapproved Human Growth Hormone (HGH)"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 1/10/2022 updates the name of the alert, alert subtype, the reason for alert, guidance, agency contacts, charge code language, product description and PAF. Changes to the import alert are bracketed by asterisks (***).
HGH is the active ingredient in a number of human prescription drug products approved for marketing in the U.S. under *** biologics license applications (BLAs). *** FDA-approved HGH can be legally prescribed for a limited number of conditions including, ***among others:
• Treatment of children with growth failure or short stature due to chronic kidney disease, growth hormone deficiency (GHD), idiopathic short stature, Noonan Syndrome, Prader-Willi Syndrome, short stature homeobox-containing gene (SHOX) deficiency, Small for Gestational Age, or Turner Syndrome; or
• Treatment of adults with adult-onset or childhood-onset GHD or short bowel syndrome in patients receiving specialized nutritional support.***
HGH has important benefits, but also serious, known risks. Among the possible long-term side effects of HGH is an increased risk of cancer. Other dangerous side effects, including nerve pain and elevated cholesterol and glucose levels, have also been reported.
*** Due to the relatively high cost of FDA-approved HGH drug products, counterfeit and unapproved products have entered the United States supply chain. The agency is also aware that unapproved HGH finished dosage form products, including lyophilized powders intended for reconstitution, have been offered for import as active pharmaceutical ingredients (APIs) intended for compounding. ***
Some pharmacies promote ***compounded HGH products for anti-aging purposes. They are sold as a "fountain of youth" in longevity clinics and to build body mass, promote weight loss, increase libido, and gain stamina. However, HGH is not approved by FDA for any of these uses.***
*** If unapproved HGH is purchased from unauthorized foreign sources or over the Internet, safeguards built into the U.S. drug distribution system may be bypassed, placing consumers who use HGH from these sources at high risk for adverse events. ***
Section 303 (e)(1)of the *** Federal Food, Drug, and Cosmetic Act (FD&C Act), *** 21 U.S.C. 333 (e)(1), prohibits knowingly distributing, or possessing with the intent to distribute, HGH for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services (HHS) under section 505 of the FD&C Act, 21 U.S.C. 355, and pursuant to the order of a physician. The Secretary of HHS has not authorized, for example, any HGH use for anti-aging, bodybuilding, or athletic enhancement. Thus, distributing, or possessing with the intent to distribute, HGH for these uses or any other unapproved use violates section 303(e)(1) of the FD&C Act. A violation of section 303 (e)(1) carries up to 5 years imprisonment and fines and, if the offense involves an individual under 18 years of age, up to 10 years imprisonment and fines.
HGH products are new drugs and cannot be legally marketed in the U.S. without an approved application. HGH products that have been approved for sale by FDA are sold either *** as injections *** or as lyophilized powders that are labeled for *** reconstitution *** by the health care professionals who dispense them. Accordingly, FDA considers both imported HGH lyophilized powder products and *** injection *** HGH products to be finished dosage form drugs, not APIs. Unless finished products are the subject of approved *** biologic license *** applications, they violate section 505 of the FD&C Act, 21 U.S.C. 355, and may not be legally imported into the U.S. Some HGH marketers may claim that their HGH drug products are intended for use in pharmaceutical compounding. ***Because these drugs are biological products subject to licensure under section 351 of the Public Health Service Act, however, they are not eligible for the exemptions for compounded drugs under sections 503A of the FD&C Act (21 U.S.C. 335a) and 503B (21 U.S.C. 353b) of the FD&C Act.***
Some HGH marketers may claim that their HGH products are dietary supplements. FDA first approved HGH as a new drug ***under section 505 of the FD&C Act, 21 U.S.C. 355,*** in 1940, and HGH was not marketed as a dietary supplement or as a food before then. Accordingly, HGH is excluded from the definition of a dietary supplement under section *** 201(ff)(3)(B) of the FD&C Act, 21 U.S.C. 321 (ff)(3)(B). Therefore, any product containing HGH cannot be a dietary supplement.***
HGH is the active ingredient in a number of human prescription drug products approved for marketing in the U.S. under *** biologics license applications (BLAs). *** FDA-approved HGH can be legally prescribed for a limited number of conditions including, ***among others:
• Treatment of children with growth failure or short stature due to chronic kidney disease, growth hormone deficiency (GHD), idiopathic short stature, Noonan Syndrome, Prader-Willi Syndrome, short stature homeobox-containing gene (SHOX) deficiency, Small for Gestational Age, or Turner Syndrome; or
• Treatment of adults with adult-onset or childhood-onset GHD or short bowel syndrome in patients receiving specialized nutritional support.***
HGH has important benefits, but also serious, known risks. Among the possible long-term side effects of HGH is an increased risk of cancer. Other dangerous side effects, including nerve pain and elevated cholesterol and glucose levels, have also been reported.
*** Due to the relatively high cost of FDA-approved HGH drug products, counterfeit and unapproved products have entered the United States supply chain. The agency is also aware that unapproved HGH finished dosage form products, including lyophilized powders intended for reconstitution, have been offered for import as active pharmaceutical ingredients (APIs) intended for compounding. ***
Some pharmacies promote ***compounded HGH products for anti-aging purposes. They are sold as a "fountain of youth" in longevity clinics and to build body mass, promote weight loss, increase libido, and gain stamina. However, HGH is not approved by FDA for any of these uses.***
*** If unapproved HGH is purchased from unauthorized foreign sources or over the Internet, safeguards built into the U.S. drug distribution system may be bypassed, placing consumers who use HGH from these sources at high risk for adverse events. ***
Section 303 (e)(1)of the *** Federal Food, Drug, and Cosmetic Act (FD&C Act), *** 21 U.S.C. 333 (e)(1), prohibits knowingly distributing, or possessing with the intent to distribute, HGH for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services (HHS) under section 505 of the FD&C Act, 21 U.S.C. 355, and pursuant to the order of a physician. The Secretary of HHS has not authorized, for example, any HGH use for anti-aging, bodybuilding, or athletic enhancement. Thus, distributing, or possessing with the intent to distribute, HGH for these uses or any other unapproved use violates section 303(e)(1) of the FD&C Act. A violation of section 303 (e)(1) carries up to 5 years imprisonment and fines and, if the offense involves an individual under 18 years of age, up to 10 years imprisonment and fines.
HGH products are new drugs and cannot be legally marketed in the U.S. without an approved application. HGH products that have been approved for sale by FDA are sold either *** as injections *** or as lyophilized powders that are labeled for *** reconstitution *** by the health care professionals who dispense them. Accordingly, FDA considers both imported HGH lyophilized powder products and *** injection *** HGH products to be finished dosage form drugs, not APIs. Unless finished products are the subject of approved *** biologic license *** applications, they violate section 505 of the FD&C Act, 21 U.S.C. 355, and may not be legally imported into the U.S. Some HGH marketers may claim that their HGH drug products are intended for use in pharmaceutical compounding. ***Because these drugs are biological products subject to licensure under section 351 of the Public Health Service Act, however, they are not eligible for the exemptions for compounded drugs under sections 503A of the FD&C Act (21 U.S.C. 335a) and 503B (21 U.S.C. 353b) of the FD&C Act.***
Some HGH marketers may claim that their HGH products are dietary supplements. FDA first approved HGH as a new drug ***under section 505 of the FD&C Act, 21 U.S.C. 355,*** in 1940, and HGH was not marketed as a dietary supplement or as a food before then. Accordingly, HGH is excluded from the definition of a dietary supplement under section *** 201(ff)(3)(B) of the FD&C Act, 21 U.S.C. 321 (ff)(3)(B). Therefore, any product containing HGH cannot be a dietary supplement.***
Guidance:
***Divisions may detain without physical examination (DWPE) all shipments of HGH drug products from firms that are identified in the Red List to this alert.
DWPE may be appropriate for shipments of HGH drug products that are not subject to an approved biologic license application (BLA) or that are otherwise not lawful to import.***
*** HGH drug products that are covered by approved BLAs may be lawfully imported.
Finished drug products that are intended solely for tests in vitro or in animals used only for laboratory research may be lawfully imported under the conditions set forth in 21 CFR 312.160. This includes being labeled in accordance with 21 CFR 312.160(a)(1)(i), and shipped in accordance with the requirements in 21 CFR 312.160(a).
Finished drug products that will be used for instruction, law enforcement, research, analysis, or testing under the conditions set forth in 21 CFR 201.125 may be lawfully imported.***
***Recommendations for DWPE for firms not listed on the Red List of this import alert should be forwarded to DIO. DIO will coordinate the review of the DWPE recommendation with CDER.***
***Release of Articles Subject to Detention Without Physical Examination under this Import Alert:
In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the products in the shipment meet relevant requirements, such as being covered by an approved BLA or meeting the conditions set forth in 21 CFR 312.160 or 201.125. ***
Commercial or promotional shipments and products subject to Import Alerts, are generally not covered by and/or amenable to the operating procedures for personal-use quantities of FDA-regulated imported products set forth in RPM Chapter 9, Subchapter 9-2: "Coverage of Personal Importations" (https://www.fda.gov/media/71776/download).
*** Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation to give the Agency confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov ***
***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving compliance of drugs or drug products subject to this Import Alert should be addressed to CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov.
***
DWPE may be appropriate for shipments of HGH drug products that are not subject to an approved biologic license application (BLA) or that are otherwise not lawful to import.***
*** HGH drug products that are covered by approved BLAs may be lawfully imported.
Finished drug products that are intended solely for tests in vitro or in animals used only for laboratory research may be lawfully imported under the conditions set forth in 21 CFR 312.160. This includes being labeled in accordance with 21 CFR 312.160(a)(1)(i), and shipped in accordance with the requirements in 21 CFR 312.160(a).
Finished drug products that will be used for instruction, law enforcement, research, analysis, or testing under the conditions set forth in 21 CFR 201.125 may be lawfully imported.***
***Recommendations for DWPE for firms not listed on the Red List of this import alert should be forwarded to DIO. DIO will coordinate the review of the DWPE recommendation with CDER.***
***Release of Articles Subject to Detention Without Physical Examination under this Import Alert:
In order to secure release of an individual shipment subject to DWPE under this Import Alert, the importer and/or another responsible party to the shipment should provide evidence that the products in the shipment meet relevant requirements, such as being covered by an approved BLA or meeting the conditions set forth in 21 CFR 312.160 or 201.125. ***
Commercial or promotional shipments and products subject to Import Alerts, are generally not covered by and/or amenable to the operating procedures for personal-use quantities of FDA-regulated imported products set forth in RPM Chapter 9, Subchapter 9-2: "Coverage of Personal Importations" (https://www.fda.gov/media/71776/download).
*** Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation to give the Agency confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or via email to: Importalerts2@fda.hhs.gov ***
***Questions or issues involving import operations should be addressed to ORA/DIO at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving compliance of drugs or drug products subject to this Import Alert should be addressed to CDER/OC/ODSIR/DGDDP/ICB at CDERImports@fda.hhs.gov.
***
Product Description:
Human Growth Hormone (HGH); *** Somapacitan-beco ***; Somatropin
Charge:
*** The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that is in violation of section 505(a) of the FD&C Act because it is unapproved and it appears to be misbranded under section 502(f)(1) of the FD&C Act because it fails to bear adequate directions for use. [Unapproved, Section 505; Misbranded, Section 502(f)(1)] ***
OASIS charge code: *** NO LICENSE ***
And/or:
***"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a drug within the meaning of section 201(g) and it lacks adequate directions for use. [Misbranding, section 502(f)(1)]."***
OASIS charge code: *** DIRSEXMPT ***
OASIS charge code: *** NO LICENSE ***
And/or:
***"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a drug within the meaning of section 201(g) and it lacks adequate directions for use. [Misbranding, section 502(f)(1)]."***
OASIS charge code: *** DIRSEXMPT ***
Countries
MULTIPLE COUNTRIES
-
(64 R - - 18) Human Growth Hormone (Hormone)
-
(64 R - - 20) Somatrem (Hormone)
-
(64 R - - 21) Somatropin (Hormone)
-
(64 R - - 22) Somatropin (RDNA Origin) (Hormone)
-
(64 R - - 23) Somatropin, Biosynthetic (Hormone)
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
Changchun GeneScience Pharmaceutical Co., Ltd.
Date Published : 08/09/2017
No. 72 Tianhe Street , Changchun High-Tech Dev. Zone
, Changchun City,
Jilin CHINA
64 R - - 21 Somatropin (Hormone)
Date Published: 08/09/2017
Desc: Somatropin rDNA for Injection
64 R - - 99 Hormone N.E.C.
Date Published: 08/09/2017
Desc: Somatropin rDNA for Injection
HENAN EXTEND TRADING CO
Date Published : 04/18/2017
30 E OF HANGHI RD
, HENAN,
CHINA
45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 04/18/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
54 C - - 01 L-Alanine (Protein)
Date Published: 04/18/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
54 C - - 99 Protein N.E.C.
Date Published: 04/18/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
56 F - - 99 Peptide N.E.C.
Date Published: 04/18/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 04/18/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
64 R - - 99 Hormone N.E.C.
Date Published: 04/18/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/18/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
HENAN EXTEND TRADING COMPANY
Date Published : 04/17/2017
860 Weilai Rd
, Zhengzhou,
CHINA
45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 04/17/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
54 C - - 01 L-Alanine (Protein)
Date Published: 04/17/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
54 C - - 99 Protein N.E.C.
Date Published: 04/17/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
56 F - - 99 Peptide N.E.C.
Date Published: 04/17/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 04/17/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
64 R - - 99 Hormone N.E.C.
Date Published: 04/17/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/17/2017
Desc: L-Alanine
Notes: Product was manifested as L-Alanine; however it was found to contain undeclared Human Growth Hormone.
Henan New Sensation Chemical Co Ltd
Date Published : 11/01/2016
No 861 Huanghe East Rd , Jingjijizhukaifa Guanchenghuizu
, Zhengzhou,
Henan CHINA
45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 11/10/2016
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
45 C - - 99 Antioxidants (Food Additives for Human Use)
Date Published: 11/01/2016
Desc: L-Alanine
Notes: Product contains undeclared human growth hormone
54 C - - 08 L-Glutamine (Protein)
Date Published: 11/10/2016
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
54 C - - 99 Protein N.E.C.
Date Published: 11/01/2016
Desc: L-Alanine
Notes: Product contains undeclared human growth hormone
54 C - - 99 Protein N.E.C.
Date Published: 11/10/2016
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
56 F - - 99 Peptide N.E.C.
Date Published: 11/10/2016
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
56 F - - 99 Peptide N.E.C.
Date Published: 11/01/2016
Desc: L-Alanine
Notes: Product contains undeclared human growth hormone
64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 11/01/2016
Desc: L-Alanine
Notes: Product contains undeclared human growth hormone
64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 11/10/2016
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
64 R - - 99 Hormone N.E.C.
Date Published: 11/10/2016
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
64 R - - 99 Hormone N.E.C.
Date Published: 11/01/2016
Desc: L-Alanine
Notes: Product contains undeclared human growth hormone
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/10/2016
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/01/2016
Desc: L-Alanine
Notes: Product contains undeclared human growth hormone
88 P - - PM General purpose reagent
Date Published: 08/11/2023
Desc: L-Alanine
Notes: Product contains undeclared human growth hormone
88 P - - PM General purpose reagent
Date Published: 08/11/2023
Desc: Glutathione
Notes: Product was manifested as Glutathione. However, it was found to contain
undeclared Human Growth Hormone.
TianXiang Liu
Date Published : 12/08/2017
NO 624 2013 Wenhua , Chuangkr Garden
, Shenzhen,
GD CHINA
64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 12/08/2017
Desc: Hygetropin
64 R - - 21 Somatropin (Hormone)
Date Published: 12/08/2017
Desc: Hygetropin
64 R - - 99 Hormone N.E.C.
Date Published: 12/08/2017
Desc: Hygetropin
Xian Lyphar Biotech Co Ltd
Date Published : 09/14/2016
Tang NO 11 , Yan Rd Hi Tech; Ind Zone
, Xian,
CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 09/14/2016
Desc: FoliGain
Notes: Product contains undeclared human growth hormone
62 C - - 41 Minoxidil (Anti-Hypertensive)
Date Published: 09/14/2016
Desc: FoliGain
Notes: Product contains undeclared human growth hormone
64 R - - 18 Human Growth Hormone (Hormone)
Date Published: 09/14/2016
Desc: FoliGain
Notes: Product contains undeclared human growth hormone
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/14/2016
Desc: FoliGain
Notes: Product contains undeclared human growth hormone