American Association of Homeopathic Pharmacists
5112 Wilshire Drive
Santa Rosa, CA 95404
Eric L. Foxman, Secretary
FOR IMMEDIATE RELEASEAmerican Association of Homeopathic Pharmacists offers Guidance on “Homeopathic Human Growth Hormone (HGH)”
The recent appearance in natural foods stores and mass markets outlets of products that are labeled as “Homeopathic Human Growth Hormone (HGH)” have prompted the American Association of Homeopathic Pharmacists (AAHP) to offer the following guidance on the topic:
- The substance called Homeopathic Human Growth Hormone (HGH) is not an official homeopathic drug, as it is not included in the Homeopathic Pharmacopoeia of the United States (HPUS). As such, there are no identity or quality standards for starting material, nor standardized processes for the manufacture of a homeopathic dosage form. Therefor, there are no official safety levels (OTC, Rx, HPN) for “HGH” determined by independent review.
- Homeopathic provings for “HGH” do not appear in the medical literature; consequently, clinical use of the substance does not have broad agreement among homeopathic experts.
- The distribution of “HGH” (1) without a prescription and (2)
which does not have an approved new drug application under Section 505 of
the Federal Food, Drug, and Cosmetic (FD&C) Act is a felony. Section
303 (f) (1) of the FD&C Act provides that:
(f) (1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses with intent to distribute human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 505 and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are authorized by title 18, or both.
(2)Whoever commits any offense set forth in paragraph (1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act for the purposes of forfeiture under section 413 of such Act.
(4) As used in this subsection, the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection.
The AAHP urges any individual with an interest in the substance to contact the Food and Drug Administration, the Drug Enforcement Administration, or their regulatory counsel for further information or clarification.