(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 Name:
Reason for Alert:
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.***
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.
OASIS charge code: *** NO LICENSE ***
***"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 ***
MULTIPLE COUNTRIES (PODS ONLY)
(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)