The Hormone Question

Secretagogues, homeopathics and injectable drugs intersect at the crossroad of consumer desires

Human growth hormone (hGH), also known as somatotrophin, is a naturally occurring hormone found in the pituitary gland and other tissues in the human body. It is essential for the growth of cells, bones, muscles and organs, and is primarily released in pulses during the beginning phases of sleep, when it is then converted in the liver to insulin-like growth factor type one (IGF-I). Like its fellow endocrine hormones (such as estrogen or progesterone), levels of hGH decline with age. Symptoms of somatotrophin deficiency syndrome (occurring in most people over 70) include loss in lean body mass, an increase in fat content and fatigue, a decreased physical mobility, a diminished ability to heal, a greater risk for cardiovascular disease and a lower life expectancy.

HGH has been used medically for children suffering from conditions such as Turner Syndrome and slow bone growth caused by renal failure, and it has been studied by physicians for its role in treating chronic fatigue syndrome and muscle building. Study results have varied as to the effectiveness of injectable hGH for these conditions. One study involving male volunteers aged 61 to 81 found that a six-month treatment with hGH resulted in more energy, decreased body fat and increased lean muscle mass (NEJM, 323:1-6, 1990). However, another study involving healthy athletes did not increase strength (J Endocrin Invest, 22:5 106-9, 1999). Injectable hGH is made using recombinant DNA technology, as the previously used hGH extracted from the pituitary glands of human and animal cadavers led to neurological diseases such as Creutzfeldt-Jakob disease (similar to "mad cow" disease).

But where does this information fit into the world of dietary supplements? After all, in the United States, hGH is a regulated drug under section 303F of the Federal Food, Drug and Cosmetic Act. Anyone who knowingly distributes or possesses with intention to distribute hGH (as somatrem, somatrophin or an analogue of either) not for treatment of a disease or medical condition may face up to three years in prison and a stiff fine. "The sale of hGH as a dietary supplement is illegal and a felony," stated Brad Williams, special assistant in the Division of Compliance and Enforcement, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration (FDA).

Homeopathic hGH

The law is clear on selling hGH as a dietary supplement. However, there are two classes of supplements that may offer the benefits consumers are seeking (anti-aging, muscle building, etc.) without selling actual hGH. First is homeopathic hGH.

"HGH is in the process of being accepted as a homeopathic medicine," said Dana Ullman, a homeopathic practitioner and formulator. "There are approved homeopathic medicines and not yet approved medicines. If a manufacturer makes and markets an unapproved homeopathic that doesn't mean it's not being done illegally. It means that the FDA may investigate the company and may ask for evidence that the product is a legal substance."

Homeopathic medicines have a specific regulatory structure set up with FDA. The agency began regulating homeopathic medicine in 1990, following publication in the 1980s of a restructured Homeopathic Pharmacopoeia of the United States (HPUS), which established guidelines for the manufacturing, marketing and sale of homeopathic medicines. The Compliance Policy Guide (CPG) from FDA serves as a regulatory framework; it strengthened the definition of a homeopathic drug, set forth guidelines for prescription and nonprescription homeopathic drugs and made clear packaging and labeling guidelines. The CPG also established the sale of homeopathic drugs over the counter (OTC). According to the guide, these drugs could be sold OTC provided that the homeopathic remedy follows homeopathic medicine specifications of the Homeopathic Pharmacopoeia, is non-toxic and is used for a self limiting condition that did not require medical diagnosis or monitoring. Furthermore, any drug included in the Pharmacopoeia would be considered "official" and those not included would be "non- official." According to the guidelines, any official homeopathic drug could be sold without further documentation by the manufacturer.

Homeopathic hGH is non-official. Non-official drugs require that the manufacturer produce a homeopathic "proving" or sufficient peer-reviewed clinical data for the FDA to determine if the drug is homeopathic. Homeopathic HGH is awaiting a review by FDA on various manufacturer's research and a pending monograph with the HPUS to determine the legality for these products. Currently, FDA requires that homeopathic drugs sold as OTC drug products are labeled with an established or official name of the drug on the front label panel, the active and inactive ingredients listed in terms of specified potency and at least one indication for use, according to Barbara Brewitt, Ph.D., chief executive officer and chief scientific officer at Biomed Comm Inc.

FDA will also be reviewing the research backing the claims being made for homeopathic hGH. Homeopathic hGH has undergone several provings and studies to confirm its claims and benefits. Dr. David Riley, HPCUS board member, conducted an official drug proving through the Integrative Medicine Institute in 1998, and three double-blind, placebo controlled studies were published after peer-review in 1999 (Alt.and Compli. Therapies, 5:6 372-385, Dec. 1999, ). "Many companies are citing clinical studies on injectable growth hormone and are making claims on over the counter homeopathic growth hormone based on injectable studies," Brewitt said. "These claims are violation of FDA and FTC regulations and can be considered misbranded by the FDA with new USP drug claims and considered fraudulent and deceptive claims by the FTC. The FDA requires that claims based upon peer-reviewed and published clinical studies must use the exact product that is being sold."

Transdermal homeopathics using hGH are also available; these are usually a cream that penetrates the skin and goes directly into the bloodstream, according to Fountain of Youth. This company offers a non-prescription pharmaceutical-grade homeopathic somotrophin gel that is mainly used as an anti-aging therapy, but it can also be used for improving athletic performance.

An OTC homeopathic hGH claim must appeal to a condition that is self-limiting and self diagnosable. "A definition of an OTC drug is that it is self limiting and must basically be safe," Ullman said. In Well Being Journal(May/June 2000) found that some of the following symptoms could be considered symptoms of hGH deficiency: fatigue, decreased lean mass, poor sleep, anxiety, reduced vitality, decreased lean and/or muscle mass and emotional fragility.

Williams said while he is not familiar with the Homeopathic Pharmacopoeia, it would be his understanding that any detectable levels of hGH would be a violation of the FDC act. Marc Ullman, a partner in the law firm Ullman, Shapiro & Ullman, added that FDA would certainly question if hGH is appropriate as an OTC homeopathic medicine. "I can think of no medical condition that is self-diagnosed for which it would be legal to sell hGH as a homeopathic," he said. Thus, the legal status of hGH as a dietary supplement is clear, although its status as a homeopathic remedy is still being defined.

Hormone Precursors

There is a third class of products, called hormone precursors or secretagogues, that is showing a boom in available products and sales.

These "hGH boosters" contain no actual growth hormones but are amino acids that allegedly stimulate the production of hGH. Some amino acids that affect human growth hormone levels include L-glutamine, L-arginine, L-ornithine and L-lysine. Like hGH, these substances are naturally occurring. Available in powders and tablets, these are the most common amino acids used in sports supplements, with L-arginine and L-glutamine being the most popular. Also, Millersport, Ohio-based Fountain of Youth produces an hGH "potentiator" oral supplement containing L-dopa, an amino acid derived from the mucuna plant.

As with studies conducted on injectable hGH, research results vary. One study conducted on individual amino acid supplementation found it to be counterproductive to natural glutamine levels. L-arginine supplementation reduced individual glutamine levels, while L-glutamine supplementation was found to actually slow down glutamine production (Clin Nutr 19:5 319-25, 2000). However, one amino acid, by itself, will not stimulate hormone growth production, according to Jay Caplan, a biochemist and president of Biocentrics, a manufacturer of amino acid supplements in powder form targeted at anti-aging and sports performance. In fact, one study found that an amino acid combo of L-arginine, L-ornithine and L-branched chain amino acids stimulated the pituitary gland when administered to moderately trained male athletes (Med Sci Sports Exer 31:12 1748-54, 1999).

HGH and hGH boosters may not be used by people in their 20s and early 30s as an anti-age remedy, but this is the ideal demographic for the muscle- and performance-enhancing benefits amino acids offer. Even though "doping" with injectable hGH is illegal, taking hGH boosters is not. "[Amino acids] are not hGH, they just stimulate the pituitary to create hGH," Caplan said.

The different forms of hGH-enhancing products should be taken under consideration. "A tablet by itself [as opposed to powder form] won't give you nearly enough amino acids to stimulate hGH production," Caplan stated. "Also, the powders are instantly available for the body to absorb very quickly. If you absorb it slowly, it probably won't ever make it all the way to the brain [and into the pituitary gland]."

Charles Mesko, the other co-owner of Fountain of Youth, found that an amino acid tablet could bypass the nullifying effect of stomach acid if an enteric, plant-based coating was used. "Using growth hormone [homeopathics and boosters] rejuvenates the body, making athletes recover from training much more quickly than usual," he said.

As with anything, using amino acids above recommended levels or without consulting with a medical care provider may lead to future problems. L-arginine may cause or aggravate gastritis or peptic ulcer disease, and L-glutamine may interfere with anti-seizure medication. As always, a person should be knowledgeable about the product he is taking.

Along with dosage form, the amount of ingredient being delivered should also be considered. According to Phillip Harvey, Ph.D., director of science and quality assurance for the National Nutritional Foods Association (NNFA), secretagogues and boosters require more study to see if they are bioactive, since traditional studies have shown that only high doses may stimulate growth hormone and may themselves cause side effects. "The studies that I am familiar with require high amounts of amino acids to have such an effect on the pituitary gland," he said."For example, a product that says four tablets contain 900 mg of arginine and 600 mg of ornithine, I doubt will have physiological effects. You would have to take around 15 g or more [of secretagogues] to get the same result."

Even within the secretagogue market, there is debate over whether the products are for everyone. "If a person's growth hormone isn't low, there's no point in supplementing it," Young Again's Mason said. However, Caplan's thought was that, "The pituitary gland wants to stay at the same hGH levels, so you have to trick it to accept higher levels than what it has in mind."

As Boomers continue to seek a cure for aging and as athletes look for something to give them an extra boost, expect to see more such products on the market. Retailers must be savvy enough to ask for the science behind hGH-related products as well as the products' legality and quality.

Share this article: Email, Slashdot, Digg, Del.icio.us, Yahoo!MyWeb, Windows Live Favorites, Furl
Add this article feed to: RSS, My Yahoo, Newsgator, Bloglines

Read Comments [0]