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AHPA: Review of Research Shows DMAA Not Naturally From Geranium
AHPA: Review of Research Shows DMAA Not Naturally From Geranium
SILVER SPRING, Md.—Members of the American Herbal Products Association (AHPA) will no longer be able to label 1,3-dimethylamylamine as geranium oil or as any part of the geranium plant, according to a trade requirement approved by the board of trustees at last month’s meeting. While this ingredient, also know by a number of synonyms, has been listed on product labels as derived from geranium oil, stem or extract, AHPA said a critical review of the scientific literature determined no credible evidence showed the constituent is found in geranium species (Pelargonium spp.).
The trade requirement becomes effective on Jan. 13, 2012. Nothing in the new requirement prevents labeling of any compound that is in fact derived from geranium plant materials by that compound's common or usual name.
1,3-Dimethylamylamine, also known as DMAA; 1,3-dimethylpentylamine; methylhexaneamine (MHA); methylhexanamine; methylhexamine; 4-methyl-2-hexanamine; and 2-amino-4-methylhexane, was an inhaled nasal-decongestant drug synthesized by Eli Lilly and Company in 1971 and known as Forthane. More recently, DMAA has been used in dietary supplements for weight loss and bodybuilding.
AHPA said it is sometimes referred to as geranamine due to a single report from a report in a technical institute journal, not a reputable, peer-reviewed journal of chemistry, that found DMAA was a naturally occurring essential oil distilled from geranium leaf. That study, by Ping et al. (Journal of Guizhou Institute of Technology 1996;(25)82-85), which identified the presence of DMAA in geranium, described a gas chromatography-mass spectrometry (GC-MS) analysis of essential oil obtained from steam distilling the minced, air-dried leaf of fresh Pelargonium graveolens. More than 40 compounds were reportedly detected, and 31 of them were assigned identities based on automatic computer matching to a MS spectral library.
However, AHPA said several problems have been noted with this report. A review of the chromatogram from the original paper, for example, revealed an inadequate separation of compounds for MS-library matches. Other issues with this report include significant concerns over the experimental conditions, the interpretation of data, the quality of data reporting, and the validation of findings.
"After a critical review of the existing scientific literature, and working with John Travis, manager of clinical operations for NSF International and the AHPA analytical laboratories committee, we're quite clear that this reported finding of DMAA from geranium is not scientifically valid," said Steven Dentali, AHPA's chief science officer. "There are no known-published reports indicating that this is a natural product. Any labeling stating that it is naturally occurring in geranium, or any other natural source, would need appropriate scientific evidence to support it. None has yet been found in the public domain."
Also at its July meeting, the board approved the appointment of John Doherty and Bill Carter, Esq., as co-chairs of the AHPA Sports Nutrition Committee. Doherty is director of regulatory affairs for Iovate Health Sciences, Ontario, Canada.Carter is general counsel for Bodybuilding.com, Meridian, ID. Doherty and Carter replace Erica Stump, Esq., formerly of Bodybuilding.com, who left the company in early April.
At the July meeting, AHPA also amended its existing guidance policy on Class 1 solvents.