“The MHRA has received a number of complaints about products containing DMAA, which was developed as a vasoconstrictor in the 1940s,” the Medicines and Healthcare products Regulatory Agency (MHRA) said.
“The MHRA responds to complaints about products on an case-by-case basis. MHRA encourages anyone who has a complaint or a concern to contact us with details of the product and where they bought it so that we can investigate. Whether the product is or is not of herbal origin is not relevant under UK legislation although we understand that it is under US legislation.”
Despite one retailer saying the agency had contacted it and several others, and that about 40 others were on a hit list over unlicensed DMAA products, MHRA said it had only contacted one company – Predator Nutrition.
“The MHRA are only aware of the two visits made to Predator Nutrition,” a spokesperson said, although it had earlier said four retailers had been warned over two DMAA products – USP Labs’ OxyElite Pro and Ergophram’s Ergopharm Ergolean AMP.
Richard Dennett, of Aurora Nutrition, said his company had been contacted, with specific products mentioned and a herbal product crackdown was in full swing.
“The MHRA statement conflicts with what its Borderline team are actually saying to retailers on the ground,” Dennett said in a comment on NutraIngredients.
“Jack3d was the first product we were told to remove.”
“They have told us, categorically, that DMAA must be withdrawn from sale, cannot be advertised, that enforcement on herbal supplements was now geared up for 2012 prior to the Olympics and that over 40 retailers were on the initial list.”
“Having spoken with around 10 other small retailers they have all had visits from either the MHRA, Environmental health or trading standards (the latter two acting on behalf of the council with MHRA backing) in regard to DMAA and herbal supplements.”
Dennett added: “We're happy to remove all DMAA products as we do not wish to break the law though we're terribly confused by this sort of statement which doesn't jibe with what we're told by enforcement officers on our store premises while they work through inspecting our shelves and telling us we're criminals for retailing products that we had no notice of changes until 3 or 4 people demanded entry.”
The MHRA said no such messages had been transmitted.
“We are not aware of anyone linking the Enforcement of the EU Traditional Herbal Medicinal Product Directive (THMPD) to the Olympics. Borderline has received a complaint listing a number of sports supplements sold by a number of companies and we will work our way through it.”
The agency said USP Labs’ Jack3D was under investigation. “Jack3d is sold as a powder and has been referred to the MHRA and is under active consideration." But as a ‘live case’ no further details were available.
It said in 2011 seven supplement products had been deemed unlicensed medicines by presentation of function or both. Five had been deemed non-medicinal.
Bigger picture
MHRA joins 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.
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.
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 .”