By Stephen Daniells, Nutra Ingredients USA
DMAA, a substance used in sports and weight loss supplements and reported by some to be a natural constituent of geranium oil, is not isolated from plants and products containing it need drug authorization, Health Canada has announced.
DMAA or 1,3-dimethylamylamine (also known as 1,3-dimethylpentylamine, methylhexaneamine (MHA), methylhexanamine, and several other names) is currently used in dietary supplements for weight loss and bodybuilding.
While the use of the compound in such supplements in the US is allowed, the situation north of the border is different: In a classification of DMAA dated July 7, 2011, by the Natural Health Products Directorate (NHPD) and Therapeutic Products Directorate (TPD), Health Canada has announced that products containing the DMAA must now be authorized as drugs.
The compound
American pharmaceutical giant Eli Lilly filed a patent on DMAA in 1944 and trademarked the compound as Forthane in 1971. It was used as a nasal-decongestant. The World Anti-Doping Agency lists MHA/DMAA as a prohibited stimulant in competition .
According to a single analysis by Chinese researchers reportedly using gas chromatography – mass spectrometry (GC-MS) techniques and published in the Journal of Guizhou Institute of Technology (1996, Vol. 25, pp. 82-85), DMAA is a constituent of geranium oil, but no other published analysis has reported its presence.
Health Canada notes in its classification that the Chinese paper contains ‘errors’, and adds that at least seven other papers have failed to identify DMAA in geranium oil.
The classification concludes: “NHPD and TPD have jointly concluded that there is no credible scientific evidence that DMAA is captured as an isolate of a plant […] and therefore cannot be classified as an NHP [natural health product].”
“In addition, DMAA is not considered to be an acceptable non-medicinal ingredient in drugs or NHPs or as a food additive due to its pharmacological activity.
“Any product containing DMAA requires authorization by Health Canada as [a] drug in order to be sold legally in Canada.”
No surprise
Ed Wyszumiala, general manager of dietary supplement programs at NSF International, told NutraIngredients-USA that he was not surprised by Health Canada’s classification.
“This again shows that DMAA is an active pharmaceutical ingredient (API) and not a dietary ingredient,” he said.
“This synthetic ingredient has a history of use as an API in the US and I would hope FDA would look to the steps Health Canada has taken to classify this compound in the proper category.”
FDA
A spokesperson from the US Food & Drug Administration (FDA) told NutraIngredients-USA yesterday that the agency is aware of the information from Health Canada.
However, “FDA has taken no action against this product nor announced any administrative action that would address its status under the Act”.
ABC
Mark Blumenthal, founder & executive director of the American Botanical Council (ABC), told NutraIngredients-USA.com that it was difficult to predict to what extent the Health Canada classification may have on any direct regulatory impact on any current marketing of any DMAA-containing dietary ingredients in the US (eg, "geranium oil").
“However, insofar as the Canadian health authorities state they have discussed this matter with the US FDA and the US Anti-doping Agency, some type of regulatory action would not be surprising.
“This could manifest as warning letters, a public warning, or possibly product recalls, etc,” he added.
Source: http://www.nutraingredients-usa.com/...%2BText%2BNews
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