By Stephen Daniells Nutra Ingredients USA
A new analysis from US Army scientists and NSF International finds, yet again, that controversial compound DMAA (1,3 dimethylamylamine) is not found in geranium. The analysis supports FDA conclusions that the evidence is ‘insufficient’ to support the use of DMAA as an ingredient in dietary supplements.
The analysis, which employed ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS), also showed that some pre-workout dietary supplement products purchased mid to late 2012 still contained the ingredient, several months after FDA sent warning letters.
In an email to NutraIngredients-USA, Ed Wyszumiala, General Manager of NSF International’s Dietary Supplement Certification programs, said: "The dietary supplement products [used in this study] were purchased in 2012, mid to late year, after the warning letters in April and before the recent FDA consumer notification. The paper took about a year to compile all the data, grow and authenticate the plant samples and perform the testing and submit it for review and obtain acceptance from the journal.
"The problem is, even with the recent FDA warning, products are still found on the shelves with this ingredient and on the internet."
The analysis, published in Drug Testing and Analysis , is in agreement with other studies that have failed to find DMAA in geranium plant material, including an analysis published in the Journal of Analytical Toxicology in June 2012 described as ‘comprehensive’ and ‘robust’ by respected members of the industry .
DMAA (also known as methyl hexaneamine (MHA) and several other names) has been a subject of intense debate about whether it is in fact a constituent of geranium. The ingredient was first manufactured synthetically by drug giant Eli Lily in the 1940s.
Only three analyses have reported it to be a natural constituent of geranium: The controversial ‘Ping Paper’ by Chinese researchers published in the Journal of Guizhou Institute of Technology (1996, Vol. 25, pp. 82-85), and two recently published papers in Analytical Chemistry Insights funded by USPLabs.
After several years of controversy, FDA issued a Consumer Update in April, which stated the agency’s position that the “information insufficient to defend the use of DMAA as an ingredient in dietary supplements”.
FDA issued 11 warning letters in April 2012 to manufacturers and distributors of supplements containing DMAA, stating that DMAA was not a lawful dietary ingredient because it lacked a New Dietary Ingredient notification, and raised the issue of whether it is a so-called synthetic botanical.
Speaking with NutraIngredients-USA at the time of the Consumer Update, Daniel Fabricant, PhD, director of FDA's Division of Dietary Supplement Programs, said: “We want to be clear about where we are. We don’t want people using DMAA.”
All of the companies cited by FDA in the warning letters are said to have agreed to stop using DMAA in their dietary supplements .
Led by Krista Austin from the US Army Research Institute of Environmental Medicine, the researchers analyzed plant species, Geranium and Pelargonium, popular dietary supplements, and commercial Geranium and Pelargonium oils for the presence of DMAA.
Results showed no measurable levels of DMAA in the plants or the essential oils at a detection limit of 1-2 ng/g.
The supplements were found to contain DMAA at levels a ranging from 0.11% to 673%.
The scientists concluded: “DMAA is not present in specific, validated cultivars of the plant species, Geranium and Pelargonium, or in the commercial essential oils selected for analysis.”
Source: Drug Testing and Analysis
Published online ahead of print, doi: 10.1002/dta.1491
“Analysis of 1,3 dimethylamylamine concentrations in Geraniaceae, geranium oil and dietary supplements”
Authors: K.G. Austin, J. Travis, G. Pace, H.R. Lieberman