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Brief and Straightforward Guide on: FDA Regulation About HGH

History of the bio-synthetic Human Growth Hormone

The first attempt to treat Growth Hormone deficiency, date’s back to the 1920s, when bovine Growth Hormone (rBGH) was purified and used in Growth Hormone deficient humans. However, the use of bovine Growth Hormone was unsuccessful, as the molecular structure of bovine GH differed considerably, compared to the human GH structure. This treatment was thus abandoned.

This was followed by the use of naturally occurring Human Growth Hormone from cadavers, in the late 1950s. The first successful treatment was done by endocrinologists at the Tufts University, Boston, when GH from the Pituitary gland of a cadaver was used for treating GH deficiency. Subsequently, this treatment regimen was used throughout the United States for the management of Growth Hormone deficiencies in humans. It was later found, that the use of this technique resulted in HGH getting contaminated by agents, causing the ‘Creutzfeldt-Jakob disease’ among the users. The disease is a degenerative disorder of the brain, which is incurable and fatal. The symptoms of the condition include: progressive dementia, hallucinations, personality changes and memory loss. This treatment was consequently stopped due to these grave side effects.

Concurrently, in 1981, an American pharmaceutical company, Genentech, developed the first bio-synthetic HGH. This form of synthetic recombinant Growth Hormone (rhGH) is produced using a technique called the Inclusion Body Technique. Subsequently, the technology was improved up on, and a new technique was developed which was referred to as the Protein Secretion Technology. This technique is now being used for the production of synthetic recombinant Human Growth Hormone.

Food and Drug Administration Regulations

Research studies conducted in the mid 1990s, indicated that, the Human Growth Hormone has several benefits, which included, reduced adipose mass (i.e. body fat), increased lean body mass, increased exercise capacity, younger-looking skin, etc. Many researchers labeled HGH as the ‘miracle hormone’ which could repeal the signs of aging, and make older people look and feel younger. Further, the Pharmaceutical industry has been keen and is pushing for the use of HGH treatment for chronic fatigue syndrome, obesity, anti-aging and fibromyalgia.

However, the lack of adequate research has made the FDA regulate the indiscriminate use of the hormone therapy. Currently, the FDA allows the use of the hormone for the management of:

• Human Growth Hormone Deficiency
• Chronic renal insufficiency
• IUGR (Intra Uterine Growth Retardation)
• Turners Syndrome and Prader-Willi Syndrome
• Cachexia

As per the United States Federal Food, Drug and Cosmetic Act, section 303F, the distribution or possession of HGH without a medical condition or a prescription, is illegal, and would invite imprisonment and fine. The purchase of injectable HGH mandates the need for a medical prescription and can not be purchased as an OTC (Over the Counter) product. The FDA prohibits the use of injectable form of HGH for supplementary purposes.

FDA regulation for other HGH products: Homeopathic HGH and HGH supplements

• Homeopathic Products: As per the homeopathic Pharmacopeia of the United States (HPUS), the Homoeopathic products have to comply with some basic standards which include, being prepared as per the specifications of general pharmacy and relevant sections under HPUS, they should have submitted documentation to verify their safety, effectiveness and relevant data regarding their toxicity. The sale of Homeopathic products as OTC product is legal as per the Compliance Policy Guide of FDA, section 400. There are several Homeopathic HGH products, that are available. These products are in the form of sprays, creams or oral pills which claim to stimulate the Pituitary gland to enhance the production of naturally occurring HGH. It is definitely prudent to buy Homoeopathic HGH supplements that are manufactured in an FDA - supported laboratory, having high quality U.S. pharmaceutical grade ingredients, and sticking to stringent GMP and HPUS guidelines. FDA also makes regular inspections, where they ensure that every bottle of Homeopathic HGH has an expiry date, and has been stamped with a ‘lot number’. This is one way how you could confirm whether the company has been approved by FDA or not.

• HGH supplements (Boosters): HGH supplements are available in the form of pills or powders. These supplements include various amino acids, glutamine, arginine, ornithine, lysine and phenylalaine, some herbs and other products. No studies have been conducted to review their efficacy; however, they are free from potential side effects, and according to various testimonials, have been found to be fairly effective and successful. Since, these products are just supplements containing amino acids, herbs and naturally occurring material, they are not regulated by the FDA, and can be purchased without medical prescription. On the other hand, many of the manufacturers tend to make false claims about their products, and the customer has to beware about spurious products.

Some facts about HGH and Food and Drug Administration

The Food and Drug Administration has very stringent policies regarding the usage of HGH. The conditions under which the products can be used have already been mentioned earlier. Hence, the availability of injectable HGH is fairly limited, and is produced by some of the major pharmaceutical companies in the United States. HGH is actually imported from other countries and repacked in the United States. This is one of the reasons why the costs of HGH products are exponentially increasing. The use of HGH products (injectable form) has been found to be the most effective. However, the FDA has limited the use of these products, as these products have been associated with several potential risks and complications. Risks include - swelling of the feet and hand, joint pain, increased susceptibility to develop diabetes and colon cancer, gynecomastia in male users, etc. The risks of complications are directly proportional to the length of usage of the HGH injections and the dosage. The side effects with the use of OTC HGH products have been limited and rare, though they include - abnormal increase of bone size of the hands and feet, insulin resistance and thicker skin.

The overall objective of the FDA regulation is to prevent the indiscriminate and unscientific use of HGH supplements, and thereby protect users from the severe and detrimental side effects.