There should not be a ‘trial by the press’ on the controversial stimulant DMAA (1,3-Dimethylamylamine), says the Council for Responsible Nutrition (USA).
The supplement industry’s trade associations, along with the Food and Drug Administration (FDA), have been under pressure to clarify the status of DMAA in recent weeks following the recall of DMAA-containing products from military bases and a lawsuit filed against USP Labs alleging the DMAA in its Jack3d and OxyELITE Pro supplements is in a “synthetic form that is both illegal and dangerous”.
A paper just published in the journal Drug Testing and Analysis has also added fuel to the debate by asserting that geranium does not contain DMAA and that “the use of the name Geranamine for this compound appears to have been a marketing ploy.”
CRN: We’re discussing this at board level
The American Herbal Products Association (AHPA) has advised members not to label DMAA as geranium oil or any part of the geranium plant – a stance supported by the United Natural Products Alliance (UNPA).
The Natural Products Association (NPA) has “no comment on this issue at this time”, while CRN vice president, scientific & regulatory affairs Duffy MacKay said the CRN was still debating the issue.
“The CRN has not developed a formal position on DMAA yet. But we will be discussing this at board level and we’ve sent out a memo to help determine next steps. We are considering a number of issues around what DMAA should be called on the label as there are multiple names in the marketplace [1,3-dimethylpentylamine, methylhexaneamine (MHA), methylhexanamine, geranium stem, geranamine, etc etc].
“DMAA is on the WADA (World Anti-Doping Agency) list and it should be as easy as possible for people to determine if a product contains it.”
Manufacturer’s responsibility to establish safety and compliance
But he added: “We can all be commentators but there shouldn’t be a trial by the press.
“Any manufacturer should be able to demonstrate the legal validity and safety of its supplements. But in the case of USPLabs it appears the company is trying to do this [USPLabs cites several safety studies on its website and has commissioned new research it says indicates that DMAA is found in geranium oil]. So we will have to watch this space.”
ABC: Is it safe?
American Botanical Council (ABC) executive director Mark Blumenthal said he welcomed the AHPA’s labeling stance as even if it were determined that DMAA is in geranium, the sheer quantity of raw material needed to produce even small quantities of it suggested that “from a chemical engineering and economic point of view” it was highly unlikely that the DMAA used in supplements was extracted from geranium.
However, there was confusion when the AHPA first announced its labeling policy, he said. “They put out two press releases in 24 hours, which caused confusion; a number of people contacted us about this.”
The first contained quotes from chief science officer Steven Dentali saying he was not aware of "any appropriate scientific evidence to support” the contention that DMAA was in geranium oil.
But the second said the AHPA had not concluded that DMAA definitely wasn’t in geranium oil and referred to new unpublished research suggesting that it might be.
Blumenthal added: “If DMAA is chemically synthesized it would appear to be an NDI for which there is no proper notification. But the more important question is, is it safe? Someone should do a critical review of the existing safety studies out there.”
A domino-like effect
Anthony Almada, a biochemist and president and chief executive of performance nutrition company GENr8, said it was “just a matter of time” before the DMAA story reached an explosive conclusion, adding: “There is going to be a domino-like effect.”
“The lawsuits, the military recall and adverse events reports put this in a different perspective. If you look back a year and a half ago, many firms were still listing geranium oil or stem on packs. In recent months, you see them just listing the chemical name.”
As for regulatory action, he said: “The FDA is definitely aware of concerns about DMAA but for it to take action it will probably take more adverse event reports.”
USPLabs: New safety studies
USP Labs cites several safety studies on its website (click here ) including one eight-week study feeding OxyELITE Pro to 32 exercise-trained men and women published in Nutrition and Metabolic Insights last month and a new 10-week study on Jack3D with 25 exercise-trained men – with results pending publication.