FDA Regulations about HGH in OTC Market

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The Human growth hormone plays a vital role in the normal development of a human being and any deficiency of this hormone would cause the human body to have growth problems. The HGH hormone is produced in the pituitary gland and the production of hormone somewhat reduces as the human body grows old. This causes many side effects affecting the different aspects of daily life. If the pituitary gland does not function properly among children then the children will not grow well. HGH deficiency was identified for the first time in 1950’s and doctors came to an agreement that it is a cause for concern and needs to be treated. Nobody knew back then as to how to overcome this deficiency through drugs. Previously the doctors as a remedial measure obtained the HGH from human cadavers. However over a period of time they noticed other complications arising due to this such as the Jacob disease.

Soon doctors found out a bio synthetic form of the human growth hormone which is a prescription drug and this drug has been approved by the FDA (Food and Drug Authority) and its regulations. However there are some pre recognized conditions as per the FDA rules under which circumstances the HGH can be given to the patient.

The reasons under which the HGH should be prescribed are:

  • A person with the human growth hormone deficiency
  • People with turner’s syndrome
  • If a person has IUD or intrauterine disorders and intrauterine growth retardation
  • Height problems in adolescence
  • Cachexia
  • Renal problems like the chronic renal insufficiency
  • Prader-Willi syndrome
  • Other than the above listed conditions there are no more rules in the FDA regulations that suggest that the HGH can be given to anybody. However many companies believe that there can be more to the human growth hormone drug and its application can be varied to many more conditions like the fatigue disorders, obesity and also help athletes and other sportsmen achieve a lot more if used as a vitamin booster.

    The FDA clearly states in its rules that selling of the HGH without a prescription as a vitamin are against the rules and is illegal. It violates the rule in section 303F and the US food, drug and cosmetic act because the section prohibits any distribution of Human growth hormone to people who do not have the deficiency and do not fall under any of the other categories. The offence is punishable.

    There are other homeopathic medications which claim that they have the HGH in a diluted form and hence are legal as per the FDA; however there are limitations to this rule because the drug can be certified only if it is listed in the Homeopathic Pharmacopeia of the United States (HPUS).

    The enhancers or the secretagogues are related to the HGH and boos the HGH production of the body but they do not contain any growth hormones in their contents.