DMAA-containing Jack3D and products like it are unauthorised drugs and being stripped from UK retail shelves and online catalogues as part of a crackdown against sports supplements by the medicines regulator, the MHRA.
The Medicines and Healthcare products Regulatory Agency (MHRA) has told several companies they must stop selling products like Jack3D, OxyElite, Hemo Rage Black and Dexaprine that contain DMAA (methylhexaneamine/1,3-dimethylamylamine).
The MHRA action makes it the first European member state agency to act against the controversial stimulant but a whole range of products not carrying registrations under the Traditional Herbal Medicinal Products Directive (THMPD) are in its sights.
“The MHRA is looking at a number of companies selling a variety of products marketed as sports supplements but which may turn out to be medicines,” a spokesperson said.
One retailer – Predator Nutrition – was urging customers to buy the products before they were removed from its catalogue at the end of next week.
Reggie Johal, founder of the four-year-old company, today posted a long missive on the company’s Facebook page urging the sector to band together to fight against, “infringement of personal liberty as well as an abuse of power by unelected public servants”.
“We have been told by no less than the head of the MHRA’s division responsible for borderline medicines, that the action is part of a drive against the industry,” Johal wrote.
“We have confirmed with some other retailers who have had products seized or been served warning letters and intelligence suggests this action will be stepped up now.”
“We will be trying to get a co-ordinated response from others in our industry to combat this action. Either we stand together and make a stand now or we will be picked off one by one until there is no-one left.”
Predator’s marketing manager Hassan Muzaffar said the company was in the process of complying with the MHRA’s request and products would be removed by the end of next week.
The company said it had also been told to remove products containing a long list of ingredients including synephrine, yohimbe, milk thistle, valerian, GABA and DHEA.
Another retailer commented on NutraIngredients: “We've been contacted by the MHRA and told to remove all products with DMAA but especially Jack3d as a named product. There doesn't appear to be any medicinal claims made on advertising but as it's a US label product it may not be EU compliant now. To be honest the MHRA didn't sound as if they knew what was going on themselves.”
"wise decisions are necessary..."
Italian-based EU food law expert Luca Bucchini welcomed the MHRA action, and highlighted the fact that DMAA does not possess either a medicines or novel foods registration in the EU.
“There has been a growing concern that lack of enforcement of EU food safety law in the UK is undermining the single market, as illegal products flow to the rest of the EU,” he said.
“Perhaps, as several member states recently suggested, we should have a free trade agreement with the US, and it should include dietary supplements as well. However, till that day, it is necessary that, for the benefit of consumers and for the integrity of the single market, rules are enforced.”
“With the Olympic games approaching, and the damage that DMAA has done to athletes and to sports nutrition, wise decisions are necessary - for the sake of all parties involved.”
MHRA guidance on what constitutes a medicinal product can be found here.
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.
Jack 3D and OxyElite manufacturer USP Labs has defended its products, stating: “DMAA has seven peer-reviewed, published clinical trials supporting its safety when used as directed, all of which can be viewed at dmaaresearch.com."