HGH : Human Growth Hormone

FDA Regulations on HGH in OTC Market

HGH hormone is produced and secreted by the pituitary gland. Decline in levels of HGH with increasing age could create health issues like impaired growth. Acceptance of HGH for medical treatment dates back to 1950's when doctors used to obtain it from human cavaders. But soon it was discovered that many batches of HGH getting contaminated by agents causing Creutzfeldt-Jakob disease in users.

A biosynthetic form of HGH created afterwards has been prescribed since 1985 in US. FDA approved the HGH injections for the treatment of-

• Human Growth Hormone Deficiency
• Turner's syndrome
• Chronic renal insufficiency
• Intrauterine growth retardation
• Prader-Willi syndrome
• Continued height deficit at puberty
• Cachexia

The decline in HGH associated with age contributes to increased visceral adipose tissue, decreased lean body mass, decreased bone mass, reduced exercise capacity, and thinning of the skin.1,3 The absence of HGH in those with GHD also is associated with an increase in cardiovascular risk factors.1 It is thought that replacing human growth hormone will counteract the normal processes of aging. The purpose of using GH-related products as athletic performance enhancers is to achieve the same results–decreased body fat and increased muscle mass to possibly increase the level of performance.

Selling of human growth hormone without a prescription as a medicine or diet is illegal. Section 303F of the US Federal Food, Drug, and Cosmetic Act prohibits the distribution or possession (with the intention of distribution) of HGH without medical condition for the treatment. Violating the law is abind by imprisonment and a fine.

Many homeopathic products claiming diluted forms human growth hormone are available. The sale of the homeopathic products as OTC products is legal according to the Compliance Policy Guide of FDA in Section 400.400. According to this 'a homeopathic drug is drug labeled as homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS)'. And the drug must meet criterias mentioned below-

• It must be safe and effective
• it must be "prepared according to specifications of the General Pharmacy and relevant sections of the HPUS"
• "submitted documentation must be in an approved format as set forth in the relevant sections of the HPUS and must include any data relevant to toxicity".

Homeopathic Products
There are Many oral homeopathic HGH (HGH) products are available without prescription. HGH creams used as anti-aging, with penetrating the skin directly goes into bloodstream. Manufacturers claims that Homeopathic HGH stimulate pictutary gland for more secretion of HGH without any side affects.

Enhancer Products (HGH Boosters)
They are often called as HGH secretagogues and available in pill or powder form. They amino acides instead of GH, causing the body production of more GH. Common amino acids used in them are glutamine, arginine, ornithine, phenylalanine and lysine. These amino acids are also common in many sports supplements. Enhancer products are very safe without any side effects ccording to manufacturers. Study has also proven the efficiency and safety of the products. Enhancer in liquid form are sprayed under tounge in mouth or nose. But no studies have been done to prove them unsafe or ineffective.

Cost for HGH lies in range of $30 to $200 per month. Many OTC products are there with false claiming to contain GH-related products with generating no hormonal growth at all.

Potential Risks
Human growth hormone use is not without potential risks and side effects. Prescribed HGH products also cause for swelling of the hands and feet, self limited musculoskeletal pain which can be treated with analgesics. Possibility of developing of carpal tunnel syndrome is there. Thyroid function and in case of diabetics or non-dibetics, glucose level should be monitored as high dose HGH can induce insulin resistance. Other conditions associated with prescription of HGH are gynecomastia, intracranial hypertension and development of antibodies to the human growth hormone protein.

Side effects though rare, have been seen with the use of the OTC products as well including elongation of the forehead, hands and feet; overgrowth of the elbows or jaw; thickening of the skin; and insulin resistance. The full benefit and potential dangers of use of OTC products are not known as little information about the ingredients in the OTC products. Patients should know the risks as well as benefits of the medicines.

What to Believe
Many companies practise applying prescription product (the injectable form of GH) to the homeopathic OTC products. But it is a violation of FDA and Federal Trade Commission regulations resulting misbranding of company. The FDA requires that information presented must be based on the exact product being sold. Pharmacists should careful look at "supporting data". Though sound good in advertisements, actual work of these products is little and conflicting in some cases.

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