August 9, 2012
DALLASUSPlabs LLC has reported a new analytical study has confirmed the presence of 1,3 dimethylamylamine, also known as DMAA, in geranium sourced from China. Results from the peer-reviewed study were published Aug. 6 in the journal Analytical Chemistry Insights.
In the study, scientists at Intertek/AAC Labs in Champaign, Ill., used a validated methodliquid chromatographyelectrospray ionization/tandem mass spectrometry (LC-ESI/MS/MS)to identify and quantify the compounds 1,3 dimethylamylamine and 1,4 dimethylamylamine from geranium (Pelargonium graveolens) plant and oil sourced from various regions in China. They found significant levels of both compounds in the samples.
"This study, confirming the presence of 1,3 dimethylamylamine and 1,4 dimethylamylamine in Chinese geranium, will put to rest any lingering questions about whether DMAA is a naturally occurring ingredient, said Kerri Toloczko, USPlabs spokesperson. It is essential to understand that because this study specifically tested fresh Chinese geranium and used a fully validated method, utilizing LC/MS/MS, designed specifically for identifying and quantifying DMAA in geranium plant and oil, that it was able to find these ingredients. Nevertheless, its presence in Chinese geranium should now be perceived as fact.
USP Labs said it has completed additional analytical studies to further corroborate the results, as well as other studies performed at a major American university that also demonstrated the presence of DMAA in geranium samples from China. The company said the follow-up research also serves to eliminate the possibility the results were due to any sort of false-positive. It noted results of these studies, as well as additional studies being completed, will be published in peer-reviewed journals in the near future.
DMAA has been in the spotlight since FDA sent warning letters earlier this year to several companies marketing DMAA-containing formulas as natural products. The agency told the companies the compound is a new dietary ingredient (NDI), making the marketed product illegal due to failure to submit proper NDI notification. FDA further stated DMAA did not have an adequate safety record and may not be legally considered a dietary ingredient because it is synthetic.
The US military halted sales of DMAA on its bases, and some retailers followed suit. However, retailers GNC and Vitamin Shoppe defended the legality of the products and kept them on their store shelves. DMAA advocates, including the companies receiving the warning letters, trumpeted the safety of DMAA and argued it is definitely found in geranium. Many disagreed with FDA's assertion that synthetic equivalents of compounds found in botanicals could not be legal dietary ingredientssynthetic versions of vitamins are allowed by FDA.
In its response to the warning letter it received, Nutrex said DMAA is found in geranium oil, which was marketed before the Oct. 15, 1994 cut-off point for NDI notifications, meaning it was "grandfathered in" and wouldn't need a notification to be currently legal as a dietary supplement. The company also offered several safety studies.
USPlabs has also offered up safety studies, reporting five clinical safety trials sponsored by the company have been published on products that contain its 1,3 -DMAA: Jack3d® & OxyELITE Pro® ingredients. USPlabs further argued more one billion servings of 1,3-DMAA-containing dietary supplements have been consumed without a single corroborated serious adverse event.
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