Breaking News on Supplements & Nutrition - North AmericaEU edition

News > Suppliers

Health Canada: DMAA is not from geranium

2 commentsBy Stephen Daniells , 24-Aug-2011
Last updated the 26-Aug-2011 at 09:53 GMT

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.

Michael McGuffin, president of the American Herbal Products Association (AHPA), added that the association "is not aware of any immediate or direct effect of this position on the U.S. status of this ingredient".

2 comments (Comments are now closed)

?

Amphetamine is found in Acacia wood. So does the FDA require all Adderall prescribed to 10 year olds be naturally extracted from Acacia? No, it's made synthetically.

Muscletech, a multi million dollar nutritional supplement company now provides a patented Geranium Extract from Geranium robertianum. Why would they include this if 1,3 DMAA is not found in it?

I suggest Health Canada look into Geranium robertianum for 1,3 DMAA before they make these claims. But I wouldn't expect this considering Health Canada is looking to regulate ALL dietary supplements. Slowly but surely. Hopefully the FDA leads on this issue, rather than follow a second rate totalitarian health system.

Canada has also banned Carnitine. Enough said.

Report abuse

Posted by Chris
26 August 2011 | 19h20

My 20 Years of Geranium Oil Research & API Testing in DS/NHP's

After 20 years of analyzing geranium oil and my recent review of 25 years of papers on the EO profile of geranium oil, I never observed this compound in it. Besides, the amine would be so stinky it would never smell like “rose geranium” it would smell like “bloated dead salmon geranium.” The paper I had translated showed major errors by the author and no other peer-reviewed publication supported this finding. All DMMA samples I tested were synthetic which can be easily determined by profiling the isomers (there are four chiral centers on the compound and on a standard GC column you get two peaks. You could get four peaks on a chiral column if you have the right phase selectivity.) There are a lot of compounds in this class that could take the place of this as there are with other API classes we test.

Report abuse

Posted by James Neal-Kababick
24 August 2011 | 18h28

Related products

Key Industry Events

 

Access all events listing

Our events, Events from partners...