The regulatory status and safety of DMAA, a stimulant used in sports and weight loss supplements and reported by some to be a natural constituent of geranium oil, has been challenged again this week.
There is an ongoing debate about whether DMAA (1,3-Dimethylamylamine - also known as methylhexaneamine or MHA), which was first manufactured synthetically by drug giant Eli Lily in the 1940s, is in fact a constituent of geranium, with the consensus growing that it is not.
Health Canada recently issued a statement arguing that DMAA is not found naturally in geranium (as many supplement makers using it claim) and affirming that any products containing it require a drug authorization.
But the US Food and Drug Administration (FDA) is yet to act on the matter, whilst trade groups are conducting research of their own.
In a complaint filed in the US District Court in the Central District of California against Texas-based USPLabs - which comes hot on the heels of an action filed last month vs Florida-based BPI Sports - plaintiff Johnnie Pacheco argues that the supplements OxyELITE Pro and Jack3d contain DMAA in a “synthetic form that is both illegal and dangerous”.
He also argues that USPLabs makes false and misleading statements about the supplements' legality, safety and efficacy. (Click here to read the complaint in Courthouse News.)
The plaintiff seeks damages on behalf of all persons in California who purchased OxyELITE Pro and/or Jack3d at any time during the past four years.
FDA draft guidance on NDIs repeatedly cited in complaint
Citing the FDA's recent - and highly controversial - draft guidance on new dietary ingredients (NDIs), the complaint notes that the FDA considers that synthetic botanical constituents are not dietary ingredients, even if they are chemically identical to their ‘natural’ counterparts.
It adds: “Defendant’s DMAA, because it is synthetic, cannot be a constituent of a botanical and cannot qualify as a dietary ingredient and be legally sold in a supplement… nor could it be an extract of a botanical…because it was not actually extracted from a botanical.”
Even if DMAA is a dietary ingredient from geranium that was grandfathered in under the 1994 Dietary Supplement Health and Education Act (DSHEA), USPLabs would still need to file an NDI notification for OxyELITE Pro/Jack3d to use it legally, claims the plaintiff.
This is because the chemical composition of the allegedly geranium-derived DMAA used in USPLabs' supplements would probably not be the same as any geranium extract grandfathered in under DSHEA, he argues, again referring to the FDA’s hotly-disputed draft guidance on NDIs.
Finally, the plaintiff argues that “no reliable clinical research” can support claims made by USPLabs about the safety and efficacy of the two products in question.
AHPA: Don't label DMAA geranium oil
The action comes days after a decision was made to remove DMAA products from Army and Air Force Exchange Service stores and retailers ahead of an army probe into the safety of DMAA following the deaths of two soldiers found to have it in their blood.
While the American Herbal Products Association (AHPA) says it is possible that DMAA could be found in geranium oil, it recently introduced a trade requirement (effective from January 13, 2012) stipulating that its members should not label DMAA as geranium oil or as any part of the geranium plant.
USPLabs: Our products are safe and legal
A spokesman for USPLabs told NutraIngredients-USA: "We are in full compliance with all applicable regulatory requirements."
But he added: “We cannot comment at this time on the action, as it has not been served upon us."
Asked about the safety of DMAA (which USPLabs claims it sources from geranium stems), he said: "We are aware that the US Department of Defense has chosen to remove several products from their shelves, including two of ours, Jack3d & OxyElite Pro, in order to conduct a safety review of an ingredient, DMAA.
"We respectfully disagree with their decision. There is absolutely no reason to remove DMAA-containing supplements from sale on certain military facilities.
"The industry is working to ensure that product availability decisions are based on sound science, and not hearsay or erroneous media reports. We are confident that when the facts are known, the consumers' rights to make their own educated decisions will be restored.
"We stand by the safety and efficacy of our products."
Click here to read what Health Canada has to say about DMAA.
Click here to listen to an interview with Ed Wyszumiala, general manager of dietary supplements programs at NSF International, on the topic.