Beware Dodgy Performance And Weight Loss Pills – The Case Of DMAA

There are plenty of supplements out there with fake claims attached and many containing illegal substances within their formulations.  When you are selling any health supplements on line, it pays to check the ingredients list on all of the products offered, even the harmless looking ones. DMAA is one substance in the spotlight and fitness fans have been warned to avoid at all costs this performance-enhancing supplement that was blamed for the death of a marathon runner in 2012.

Recently, there was the high profile case of the Jamaican sprinter Nesta Carter losing his 4x100m gold medal from the 2008 Beijing Olympics along with his fellow sprinters including Usain Bolt. Usain lost his much coveted triple-triple gold status. A retrospective examination of Carter’s urine samples showed the presence of the banned substance DMAA (methylhexaneamine or 1,3-dimethylamylamine). The International Olympic Committee (IOC) had no choice but to strip the whole Jamaican sprint team of their medals because of the doping.

The stimulant DMAA which is an amphetamine derivative regularly appears in sports supplements globally and is the current focus of attention for medicines and health regulators. Many manufacturers claim it to be a ’natural stimulant’ with functional benefits including muscle building for weight lifting, as a dietary and weight-loss aid, and for enhancing sports performance. Incidentally, DMAA was sold as a drug for nasal decongestion but no medical use for it is authorised to his current day.

The Medicines and Healthcare Products Regulatory Agency (MHRA) working with the UK Anti-Doping (UKAD) group and a number of athletic and sports agencies has been promoting awareness of the numerous issues surrounding this particular stimulant. The agency (MHRA) has been running a ‘Week of Action’ from the 30^th January to 5^th February (2017) as part of the FakeMeds campaign to highlight the issues and risks of buying unlicensed medicines online.  

Concerns about DMAA surfaced at the turn of this century when there was confusion as to whether it was really a natural substance from Geranium plants or actually manufactured industrially. The geranium extract is often called geranamine. Toxicology and medical concerns surrounded its application following clinically recorded and anecdotal evidence. DMAA acts by constricting blood vessels of the arteries.   This leads to high blood pressure with associated cardiovascular complications such as breathlessness, various arrhythmias and even heart attack, haemorrhage – especially in the brain, seizures and stroke, nausea and vomiting, psychological and neurological damage and death. One widely reported case was the death of a 30 year old runner in the 2012 London Marathon who collapsed and died just a half-mile from the finishing line. She was reportedly using the now banned product ‘Jack3d’ which contained the substance. A couple of US soldiers have also died following ingestion of the ingredient and Australia has reported related incidences.

DMAA was banned in 2012 but it still turns up and in 2016, there were seven cases of internet based retailers selling supplements containing this substance. No legal action was taken against the retailers but the law states that individuals can face up to two years in prison along with unlimited fines. Any purveyors of unlicensed medicines can expect robust action to be taken against them, but ‘voluntary compliance’ to remove the products from the online shelf is the preferred route.  Dr Adam Carey who chairs the European Specialist Sports Nutrition Alliance (ESSNA) is widely quoted :-

“It is the sad reality that DMAA is widely available- just one company selling DMAA is one company too many. DMAA is a banned substance and has no place in legitimate sports nutrition products.”

The USA is one major source of the banned substance which is ‘policed’ by the FDA. In 2016, the EU’s Rapid Alert System for Food and Feed (RASFF) stopped imports of DMAA containing substances. A sports nutrition supplement that contained also listed synephrine and far higher levels of caffeine than might normally be acceptable. Synephrine incidentally appears in bitter orange products, and like yohimbine and ephedrine would normally be taken under medical supervision or at least under medical advice according to the MHRA web-site.

The FDA (Food And Drug Administration) in the USA which regulates amongst other products, various supplements has ordered manufacturers to incinerate existing DMAA containing stocks and discontinue production.  Whilst this happened to  Jack3d and OxyElite Pro made by USPlab in 2012, there were at least 39 products listed in 2015 available commercially in the USA. Only this month (February 2017), the California based dietary supplement distributor  Regeneca Worldwide has been ordered by a US federal court to stop selling its products containing the drug. A complaint was filed on behalf of the FDA against VivaCeuticals Inc. who were operating under the Regeneca Worldwide name for illegally distributing unapproved new drugs and unadulterated and misbranded dietary supplements.  They continued to flout the law even though warning letters were issued by the FDA in August 2012 to desist manufacture and distribution which they effectively ignored.

Any business served such an order of restriction by the FDA must comply with clear policy in the US before resuming its practice. It must at least demonstrate a capability for good manufacturing practice and proper labelling. It must also receive written permission from the FDA to resume any operations and destroy any remaining stocks.

In the UK, it is not illegal to take or possess DMAA but it can no longer be sold and distributed. Visit www.gov.uk/fakemeds for further information concerning banned substances. Jack3d was also  reformulated without the offending substance in 2013.