The United Natural Products Alliance (UNPA) says it agrees with the AHPA that supplement makers should not label the stimulant DMAA (1,3-Dimethylamylamine) as geranium oil or as any part of the geranium plant.
UNPA executive director Loren Israelsen was speaking to NutraIngredients-USA as the row intensified over whether the controversial stimulant is derived from geranium (as supplement makers claim) or is in fact synthetically-produced.
While the regulatory status of DMAA has been debated for some years, the issue hit the headlines recently following the recall of DMAA-containing products from military bases and a lawsuit filed against USP Labs for selling supplements containing DMAA alleged to be in a “synthetic form that is both illegal and dangerous”.
Labeling rule an appropriate step
While the American Herbal Products Association (AHPA) says it is possible that DMAA could be in geranium oil, it recently introduced a trade requirement (effective from January 13) stipulating that members should not label DMAA as geranium oil or as any part of the geranium plant.
Israelsen said: “We do agree with AHPA with respect to the labeling of DMAA. It’s an appropriate step in line with the science as it stands at the moment.”
But he added: “It’s our understanding that some new scientific papers on this issue will be coming out in the coming months that will bring some clarity to the issue [of whether DMAA is in fact found in geranium plants].”
But until these were published it was not possible to comment further, he said.
NDI draft guidance
As for the regulatory status of DMAA, the Food and Drug Administration’s (FDA’s) new dietary ingredients (NDI) draft guidance added a new twist to the debate, he said.
“If the DMAA being used in supplements is determined to be a synthetic copy of a botanical constituent, the FDA would not regard it as a dietary ingredient at all according to its draft guidance, and its use would be prohibited in dietary supplements [if the draft guidance is not revised].”
The Ping paper…
There is only one study that is repeatedly referenced to show that DMAA is a naturally occurring constituent of geranium oil (Ping, Z.; Jun, Q. & Qing, L. (1996), ‘A Study on the Chemical Constituents of Geranium Oil, Journal of Guizhou Institute of Technology 25 (1): 82–85).
However, many experts have criticized the study, and say they have not been able to reproduce the results.
One such skeptic is Anthony Almada, president and chief executive of performance nutrition company GenR8, co-founder and past president of EAS and co-author of more than 25 peer-reviewed nutrition research studies.
Commenting on the NutraIngredients-USA website, he said: “Let's assume that geranium DOES contain DMAA. So what! What we REALLY need to know is whether the DMAA in dietary supplements is from geranium oil, as ALL marketers have asserted at some time (or to this date).
“The Ping et al. paper, as anemic and errant as it is (go ask Health Canada), asserts 0.6% by weight of "some" seven carbon chemical, claimed by some to be DMAA. DMAA content in finished goods ranges around 5-25 mg/serving.”
'Virtually irrefutable evidence' of synthetic origin?
He added: “Anyone familiar with botanical extraction and concentration knows that to achieve a highly pure constituent (from a lower native concentration, like < 1%) is very cost, solvent, and time intensive. Moreover, and far more important to the discussion, is that little thing called enantiomeric purity.
“To date, no person nor entity has described chiral separation and characterization (analyzing all four forms of DMAA). Two doping studies have identified two of the four forms, from biological samples after ingesting DMAA-containing products.
“In collaboration with a true, global expert on chiral separation, we found the following in a leading DMAA-containing dietary supplement and in two synthetic chemical standards of DMAA: 1) all four forms of DMAA (both enantiomeric pairs), and 2) virtually equal ratios among each of the two enantiomers comprising each pair.
“If DMAA existed as a single pair of enantiomers, as do some known and recognized constituents of geranium oil, then asserting that a nearly equal ("racemic") ratio of the two enantiomers in a pair affirms synthetic origin would be dicey, and perhaps incorrect.
"But two pairs of enantiomers, as for DMAA, with racemic ratios, is virtually irrefutable evidence of synthetic origin.”
USPLabs: DMAA is from geranium, and we have new data to prove it…
But USPLabs – which makes top-selling DMAA-containing supplenments OxyELITE and Jack3d - says it has new data that corroborates the findings of the Ping et al study.
According to a note circulated by Cantox Health Sciences International associate director Barry Lynch in September 2011, data from “two independent and highly respected analytical chemistry laboratories, utilizing advanced validated analytical instrumentation and methods… further demonstrate the occurrence of DMAA in the geranium plant, Pelargonium graveolens, and its edible oil”.
The data is currently being prepared for submission to peer-reviewed journals for publication, according to Lynch.