The FSA said it was working with enforcement authorities to remove DMAA (methylhexanamine/1,3-dimethylamylamine) products from shelves, even as it confirmed that the regulatory status of the ingredient remained unresolved in the UK.
A spokesperson said that determination was in the hands of the Medicines and Healthcare products Regulatory Agency (MHRA), even though the MHRA already warned several retailers (mostly online) to remove DMAA products like USPLabs’ Jack3D at the beginning of the year.
“If they decide it is a food supplement then we will decide which regulations are appropriate for it,” the spokesperson said.
MHRA activity
While regulators around the world are condemning the stimulant that many manufacturers have been claiming is derived from the geranium plant and therefore suitable as a food supplement ingredient, the FSA said it would take no further action until the MHRA completed its own investigation, apparently now into one particular product.
“An independent advisory panel has been asked by the MHRA to advise whether a certain product containing DMAA should be classed as an unlicensed medicine and therefore subject to medicine controls,” the FSA wrote in yesterday’s missive.
“This advice may also have implications for the status of other DMAA-containing supplements.”
The MHRA would not confirm which product was under investigation, when that investigation was likely to conclude, nor why it had already issued warning letters to DMAA retailers without officially determining its status.
In recent weeks Australia’s medicines agency – the Therapeutic Goods Administration (TGA) – placed DMAA on a poisons list, joining New Zealand, most of Scandinavia, France, Ireland and other nations in acting against a stimulant that has caused more positive doping tests for elite athletes in recent years than any other substance.
When the MHRA sent its initial round of letters one online retailer – Predator Nutrition – said the agency told it to to remove a host of products containing a long list of ingredients including synephrine, yohimbe, milk thistle, valerian, GABA and DHEA.
High blood pressure, nausea, cerebral haemorrhage, stroke and death were among the health issues referenced. The agency warned people who might have taken it to visit a doctor.
