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Brief and Straightforward Guide on: FDA Approved HGH Products

FDA and Human Growth Hormone

Several research studies conducted on the Human Growth Hormone have highlighted the potential positive effects of the hormone on health and wellness. The hormone has been associated with benefits, like: reduction in fat composition of the body, whilst increasing the lean muscle mass, greater stamina and exercise endurance, improvement in the quality and texture of the skin, and a reversal in the signs of aging.

The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services, is responsible for the health of the entire population. It is the responsibility of the FDA to ensure that all human and veterinary drugs, biological products, food, cosmetics and medical devices are safe and effective. FDA is also responsible for ensuring that the public gets scientifically proven and accurate information about various medicines, supplements, foods and other products that claim to improve health.

With specific reference to HGH, the FDA regulates the distribution or possession of HGH under the section 303F of the United States Federal Food, Drug and Cosmetic Act.

Though HGH has been claimed to have innumerable health benefits, and improves health and vitality, the FDA doesn’t allow the use of the product for purposes other than those mentioned below, due to a lack of adequate research and data. The conditions where the use of HGH is approved by the Food and Drug Administration include:

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

FDA prohibits the use of HGH for any other purpose, mandates the need for a medical prescription, and defines punishment (imprisonment and fine) for breaking the law.

Why is FDA regulation of HGH important?

The first question that comes to the mind is why does the FDA need to regulate the use of HGH in the open market, if research studies claim such wonderful benefits of the product? The answer is fairly simple. The Food and Drug Administration approval for the use of a particular product for a specific condition, requires considerable amount of research, clinical trials, documentation and scientific proof. Unfortunately, most of the information that is available is based on very few research studies that were conducted on a relatively smaller sample size. As per the FDA, the generalization of these potential benefits can be done only on accurate scientific studies conducted on larger and diverse sample profiles.

Further, there are some research studies that point out certain side effects of the use of HGH products. These side effects range from generalized edema to an increased susceptibility to developing diabetes, cardiovascular disease and cancer. For this reason, the FDA has enforced stringent regulations which prevent the use of HGH for other conditions, especially considering that the manufacturers of HGH products profess to treat conditions like obesity, chronic fatigue and aging.

FDA approved products: HGH Injections

The approval of the FDA is a sign of the credibility of the product and its effectiveness. However, even with FDA approval, the product can only be purchased with a doctor’s prescription, and can be used only for few select conditions, mentioned above. Some of the FDA approved products are:

• Omnitrope: It is a recombinant HGH product which is used to manage growth failure in children occurring due to insufficient natural secretion of the hormone by the Pituitary gland. It is also used to manage Growth Hormone Deficiency in adults. The product constituent is a protein, which is produced using bio-technology.

• Saizen HGH: A type of HGH injection, which requires a doctor’s prescription. It is administered under the skin and there is no other alternative to the intra-muscular injections. The injection is prescribed on a daily basis, usually at bed time. It is meant to treat growth failure in children as the product stimulates the cellular and bone growth. The injections are given up to the onset of puberty.

• Humatrope HGH: This product is available in a sterile, freeze dried powder form and is a synthetic product. The product is used to treat stunted growth in children, especially those who have not reached puberty. The product is specifically used for girls suffering from Turner’s Syndrome. Like other HGH injections, Humatrope HGH is a prescription drug and is available only on the prescription of licensed doctors. The product can be used only under the guidance of a medical professional, to avoid complications and grave side effects.

FDA approval for Supplements, Pills and Sprays

FDA approval is essential to verify the safety, effectiveness and reliability of the products. Many supplements and sprays claim that they are FDA approved, however, there are certain facts that one should know while considering the purchase of these products. Firstly, as per the Dietary Supplements Health and Education Act (DSHEA), 1994, dietary supplements don’t require a FDA approval. Since, most of the supplements, pills and sprays do not contain HGH, they are not regulated under the FDA act.

Secondly, some of the better quality products (supplements and sprays) are manufactured in GMP approved and certified laboratories, which meet the highest standards within the United States. Hence, the product is not certified, but the procedure of developing the product undergoes rigid quality, compliance norms and standards. Research studies indicate that the natural way to elevate HGH levels is to stimulate the body to produce more HGH, rather than supplementing it with artificial HGH produced outside the body. That’s why, the use of supplements and pills is a better option than the HGH injections. On the other hand, since, they do not contain HGH, they are not regulated under the FDA norms for HGH.

Always ensure that when one uses HGH injections, the product should be approved by the FDA. However, the physician is the best judge and your best guide, to help you decide which market product would be most useful for the specific condition, and it is very essential that you consider medical advice.

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