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. These claims are a violation of FDA and FTC regulations.

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

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.

Read the full article:
http://www.hsrmagazine.com/articles/0c1feat3.html

Click here to purchase the #1 "Clinically Tested and Proven" Human Growth Hormone product