This post is about the
FDA regulation regardness HGH.On previous post We talk about the
benefit of using HGH aka human growth hormone .
HGH is a hormone which is manufactured and secreted by the pituitary gland. Levels of HGH decline as we age which sometimes causes related health issues including impaired growth. When HGH first became accepted as a medical treatment back in the 1950's, doctors obtained the hormone from human cadavers
until it was recently discovered that many batches of HGH were contaminated with agents that were responsible for causing
Creutzfeldt-Jakob disease.
A biosynthetic form of HGH was created and has been available by prescription in the U.S. since 1985. The FDA has approved injected HGH to treat the following conditions:
Human Growth Hormone Deficiency
Turner's syndrome
Chronic renal insufficiency
Intrauterine growth retardation
Prader-Willi syndrome
Continued height deficit at puberty
Cachexia
There is no other medical usage of human growth hormone that has received FDA approval. nevertheless, many companies are interested in using HGH as a treatment for
chronic fatigue syndrome, fibromyalgia and obesityas well as an athletic performance enhancer and as a treatment for certain anti aging therapies. As mentioned, the FDA has not approved HGH for these purposes and
is not likely to approve it until many clinical studies have been performed.
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.
To actually sell human growth hormone without a prescription or as a dietary supplement is illegal. Section 303F of the US Federal Food, Drug, and Cosmetic Act prohibits the distribution or possession with the intention of distributing human growth hormone without a medical condition that requires treatment. If someone does distribute or possess it illegally, he or she may face imprisonment and a fine.4
There are many homeopathic products available, however, that claim to provide a diluted form of human growth hormone. The sale of the homeopathic products as OTC products is legal, as stated in the Compliance Policy Guide from the FDA in Section 400.400. This document states that "a homeopathic drug is any drug labeled as homeopathic which is listed in the Homeopathic Pharmacopeia of the
United States (HPUS), an addendum to it, or its supplements."5 To be included in the HPUS, a drug must meet at least the following criteria: (1) it must be "safe and effective"; (2) it must be "prepared according to specifications of the General Pharmacy and relevant sections of the HPUS"; and (3) "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."6
Homeopathic Products
There are many oral homeopathic HGH (HGH) products available without a prescription. There also are HGH creams that penetrate the skin and go directly into the bloodstream. These creams are mainly used as anti aging products. Product manufacturers claim that this homeopathic form of HGH will stimulate the pituitary gland to release more HGH and that it is virtually free of side effects.
Enhancer Products (hGH Boosters)
These products are often called HGH secretagogues; they come in pill or powder form. They contain no GH, but, instead, amino acids that manufacturers claim cause the body to increase the production of GH. Common amino acids in these products are glutamine, arginine, ornithine, phenylalanine, and lysine. These substances are used in many sports supplements. Enhancer product manufacturers claim that they are virtually free of side effects and safe; however, limited studies have been done to prove their efficacy and safety. There is also an
enhancer available in a liquid form that is sprayed under the tongue, in the mouth, or in the nose. Again, no studies have been done to prove that this therapy is safe and effective.
The prices of these products range from $30 to $200 per month. Of note, many other OTC products claim to contain GH-related products but do not contain any hormone or ingredient to promote growth at all.
Potential Risks
human growth hormone use is not without potential risks and side effects. The prescription HGH products are associated with swelling of the hands and feet and musculoskeletal pain that is usually self-limiting or can be treated with analgesics.1,2 These products also are linked with the development of carpal tunnel syndrome.1,2 Thyroid function should be monitored, as well as glucose levels in diabetic and nondiabetic patients, because HGH can induce insulin resistance. Other conditions that have been associated with the prescription
products are gynecomastia, intracranial hypertension, and development of antibodies to the human growth hormone protein.2
Side effects, although rare, have been seen with use of the OTC products as well. They include elongation of the forehead, hands, and feet; overgrowth of the elbows or jaw; thickening of the skin; and insulin resistance.7 Because little information is available on the actual formulations contained in the OTC products, the full benefit and potential dangers of use are not yet known. The patient has a right to know the risks of using these products and that the possible benefits may not outweigh the risks.
What to Believe
Many companies use the prescription product (the injectable form of GH) data and apply it to the homeopathic OTC products. To do so is a violation of FDA and Federal Trade Commission regulations and can be considered misbranding. The FDA requires that information presented must be based on the exact product being sold. Pharmacists should be careful when looking at "supporting data."
Although these products sound good in advertisements, there is little and conflicting evidence that these products actually work.
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