A Food Standards Agency (FSA) spokesperson told NutraIngredients the agency was discussing the status of DMAA and products that contain it with the Medicines and Healthcare products Regulatory Agency (MHRA), after it became apparent both agencies had been expecting the other to conduct formally requested investigations.
In a previous email, the FSA said, “DMAA is regarded as a medicinal product in the UK” therefore it, “falls outside the scope of the FSA’s area of work.”
The MHRA had said sports supplements containing DMAA were not making medicinal claims and therefore not subject to medicines laws. Its borderline products team has subsequently confirmed that DMAA products are potentially medicinal.
“this is not a straight forward situation”
But the presence of sports supplement products like USP Labs’ Jack3D and OxyElite which carry no EU Traditional Herbal Medicinal Product Directive (THMPD) registration or novel foods approval for DMAA, has prompted both agencies into meetings.
“It is turning out that this is not a straight forward situation and so we are having a conversation with the MHRA and trying to get to the bottom of it,” the spokesperson said.
The FSA and MHRA join a growing list of international food and medicines agencies that have, or are, conducting investigations into its effects, usage and legality, including the US Food and Drug Administration (FDA), Health Canada, along with authorities in France, Italy and Ireland.
Adverse events, adverse sourcing opinions
Attention around DMAA has been rising due to two separate factors: Potential links to adverse events including the death of two US soldiers; and whether or not DMAA is synthetically manufactured or extracted from the geranium plant.
Manufacturers like USP Labs and retailers like GNC, along with online vendors have defended its safety record, saying the adverse event links are unproven, and defended its geranium sourcing usually referencing a 1996 study (Ping et al).
That study has been heavily criticised for inconsistency, and Health Canada has issued a statement stating that DMAA does not come from the geranium plant and all products containing DMAA require drug registrations.
Trade groups have moved against it too with the Council for Responsible Nutrition UK condemning the ingredient as unauthorised in the European Union as either a food or medicinal ingredient.
“DMAA is illegal in the EU and should be stripped from shelves,” said CRN UK technical director, Peter Berry Ottoway.
While the unaffiliated US Council for Responsible Nutrition as well as the Natural Products Association are yet to take a position on the substance, the American Herbal Products Association (AHPA) has banned members from labelling DMAA as geranium-sourced in any products.
Two class actions have been lodged in the US against manufacturers or retailers of DMAA products.
USP Labs’ has defended its products, stating: “Jack3d and OxyElite are among the most studied dietary supplements ever sold. DMAA has seven peer-reviewed, published clinical trials supporting its safety when used as directed, all of which can be viewed at dmaaresearch.com.”
The website, dmaaresearch.com, was launched in December, 2011, by USP Labs’ PR firm, Qorvis Communications.