CRN UK (not affiliated with US CRN) technical director Peter Berry Ottoway called on EU and member state medicines and food supplement regulators and trading standards bodies to crack down on an ingredient he said lacks European Union novel foods approval.
“If these products like USP Labs’ Jack3D are food supplements then DMAA needs EU novel foods approval which it doesn’t have,” Berry Ottoway said.
“If they are medicines they need THMPD (Traditional Herbal Medicinal Product Directive (THMPD) registrations which they don’t have either. So the law is clear. DMAA is illegal in the EU and should be stripped from shelves.”
“But there is a lack of desire to enforce for resourcing and other reasons so it is difficult to know when any action might be taken on this. But we have little doubt that the compound is dangerous and that there is the potential for more adverse events to occur.”
Previous DMAA-linked adverse event reports include a 21-year-old New Zealand man who suffered a brain haemorrhage after taking DMAA ‘party pills’, and two US soldiers whose deaths provoked a DMAA product ban at US military bases and a commitment from the US Food and Drug Administration (FDA) to investigate the legal status and safety of DMAA.
Authorities in France and Italy are also in the midst of investigations, while USP Labs and retailers like GNC in the US say none of the adverse events can be directly linked to DMAA, that safety has been demonstrated, and claimed geranium sourcing is demonstrated in the scientific literature.
Part of the legal ambiguity stems from the fact manufacturers like USP Labs claim DMAA is sourced from geranium while others such as third party product testers and many academics say there is no evidence to prove this, and by implication, that products like Jack3D are mislabelled.
Whose remit?
The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), told this publication that sports supplements containing DMAA were not making medicinal claims and therefore not subject to THMPD or medicines guidelines.
Such a position brings the UK Food Standards Agency into the equation although it has given no indication of any action it may take on the matter.
One UK industry observer criticised the MHRA for a lack of consistency in what it targets since the THMPD became law at the end of April last year.
“It would appear DMAA can have severe contraindications and it must be remembered that it was after all once a drug [licensed by Eli Lilly in the 1940s and trademarked as Forthane in 1971],” he said.
“It should therefore fall under the remit of the MHRA but they are very inconsistent about the kinds of products and compounds they go after. They could adjudicate on it but they keep pushing it off onto others and so nothing is getting done.”
WADA breaches
DMAA may exist in a regulatory grey zone for the manufacture of sports products but there is no ambiguity at the elite sport level where it appears on the World Anti-Doping Agency (WADA) list of prohibited substances as methylhexaneamine/dimethylpentylamine.
That state of affairs meant two athletes with DMAA in their blood were the only positive doping offences at last year’s athletic World Championships in South Korea.
And at least one Scottish footballer as well as some rugby players are fighting court cases in the UK after they failed doping controls for DMAA. In the case of the Scottish footballer, Simon Mensing, both parties are pleading innocence – USN, the manufacturer of the Xedra-Cut that the nutrients it was importing were contaminated with DMAA; the athlete that the product was not labelled with the compound.
A summary of those WADA breaches can be found here.