Growth hormone and FDA
Researchers have long realized the importance of human growth hormone. Studies into the benefits of the polypeptide date to the early part of the 20th century, maybe earlier. The observed importance even led to its extraction from cadavers to treat people with very low levels. Scientists were able to develop a synthetic version of the natural substance, which they called somatropin, in the 1980s. The discovery marked impressive turnaround in the treatment of people with growth hormone deficiency.
However, few years after the introduction of synthetic HGH, studies started to show that it offers several other amazing benefits. These include fat loss, increase in lean muscle mass, younger-looking skin and better exercise performance. The findings made many people eager to want to try the peptide to deal with signs of aging. This made it necessary to control the use of this powerful substance, considering potential for side effects.
The FDA is an agency of the U.S. government, under the supervision of the Department of Health and Human Services. Its duty is to safeguard the health of Americans by making sure food, drugs and other products are safe for consumption or use. HGH is regarded a powerful drug and, as such, falls under the control of this agency. The United States Federal Food, Drug and Cosmetic Act (section 303F) empowers the FDA to regulate the distribution or possession of somatropin. So, the determination of what you can use growth hormone for is within its domain.
Necessity for regulation
Now, you may ask what the need for the FDA to control what you can use HGH for is. A major reason for this is that the regulatory agency does not yet have sufficient or convincing research evidence that you can use this substance for other purposes other than the ones it recognizes. Most of the few studies available on off-label uses had very small sample populations. This makes it practically impossible to make generalizations based on their findings. In some cases, subsequent researchers aren’t able to replicate earlier studies.
We could also say the need for regulation has to do with safety. As previously noted, you are dealing with a powerful substance here. You can expose yourself to nasty side effects if you use it wrongly. It is not ideal for use by people with ideal HGH levels for their age. So the FDA prefers to allow use only when there is confirmed deficiency.
What are the approved uses?
There are very few purposes for which the use of HGH is approved by the FDA. These mostly concern children in that growth hormone deficiency can prevent them from reaching normal adult height. It is approved for the correction of the following, as affects children:
- Growth hormone deficiency
- Growth-related issues resulting from Prader-Willi syndrome, Turner’s syndrome or chronic renal insufficiency
- Idiopathic short stature
- Being small for gestational age at birth or intra-uterine growth retardation (IUGR)
Years after approval for use in children, the FDA approved synthetic HGH for treatment of adult patients in 1996. It can be used to treat those with growth hormone deficiency linked, among others, to:
- Cachexia or muscle wasting (as seen in people with HIV/AIDS)
- Short bowel syndrome
However, the original approval for use in adults had conditions attached. HGH is meant only for growth hormone deficiency of known origin, such as trauma, pituitary tumor, irradiation, or hypothalamic disease. But some patients have their low HGH levels attributed to other causes than these ones.
Other uses of growth hormone that are supposedly licensed in the United States include treatment of:
- Skeletal dysplasia
- Down syndrome
- Noonan syndrome
- Aarskog’s syndrome
- Rheumatoid arthritis
- Short stature due to long-term steroid use
Approved HGH products for therapy
In line with its oversight role, the FDA has granted approval to some HGH products. These contain real hormone and are to be specifically used for treatment of medically diagnosed patients. You can only get these products on prescription from your doctor. The type that will be prescribed to you will depend on the particular condition you have been diagnosed to have. They are all given as injections.
Genotropin – This recombinant growth hormone serves a variety of purposes. Doctors use it to treat growth failure or, generally, growth hormone deficiency. It is used to deal with muscle-wasting or weight loss from HIV and for short bowel syndrome.
Humatrope – Available as freeze-dried, sterile powder, this product is for treatment of stunted growth in children. It is more commonly used to treat female children with Turner’s syndrome.
Omnitrope – Made by Sandoz Inc., this synthetic HGH product addresses growth failure in children due to low growth hormone production. Generally, it can be used for treatment of HGH deficiency, including in adults.
Other HGH products having the approval of the FDA include:
What’s the right way to access HGH therapy?
Somatropin is a prescription substance. This means the ideal way to get it is through your doctor. It is important however that the medical professional you approach should have special knowledge of hormone therapy. The ideal ones to approach are typically certified endocrinologists. Doctors who specialize in age management or anti-aging medicine can also be approached.
Certain evaluations will have to be done in determining whether you are qualified to get HGH. Your doctor will carry out full medical examination and request blood testing. The results of the tests must show you meet the FDA’s strict requirements to get growth hormone prescription. Ideally, therapy should be supervised by a qualified medical professional. This will ensure the doses taken are safe for your overall health and wellbeing.
In the event you cannot find an HGH treatment expert in your area, you may be able to get prescription online. But note that blood check and other necessary evaluations would still need to be done to get a prescription.
Can you get HGH for off-label purposes?
Under federal laws, it is not permitted to use growth hormone for purposes other than those authorized by the FDA. So you may not use it for off-label benefits such as promotion of glowing skin, aesthetic weight loss or bodybuilding.
Doctors, however, seem to enjoy a degree of freedom in deciding what to prescribe the substance for. This depends on where they operate in most cases. While these professionals are required to prescribe HGH only for approved uses, the FDA is said to not monitor what it is prescribed for in individual practice.
But the drug and food regulator, alongside the US Drug Enforcement Agency (DEA), is empowered to investigate violations of laws on use of HGH. Those found with somatropin without prescription (for use or distribution) or with illegal products can be prosecuted. Possible penalties include forfeitures, fines or jail term.
Growth hormone, no doubt, offers amazing benefits to make you want to supplement with synthetic HGH. But, unless you are diagnosed with a condition approved by the FDA, you will be taking a risk by doing this. Your best bet for off-label uses are, perhaps, HGH releasers that promote natural growth hormone production. A good example of these is HGf Max.