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FDA Regulations regarding
Human Growth Hormone (HGH) in the OTC Market
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FDA Regulations regarding
Human Growth Hormone (HGH) in the OTC Market
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 quickly 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.
For a list of references, send a stamped, self-addressed
envelope to:
References Department, Attn. D. Ryan, Pharmacy Times, 241
Forsgate Drive,
Jamesburg, NJ 08831; or send an e-mail request to: dryan@mwc.com.
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