Time to act on unauthorised DMAA-geranium sports products in Europe?

19-Oct-2011 - Last updated on 21-Oct-2011 at 16:57 GMT

Related tags Food and drug administration Dmaa

Jack3d: Contains 1,3-dimethylamylamine, which in Italy at least, is not authorised for use in food supplements

Sections of the European botanicals industry are beginning to raise red flags about DMAA, the synthetic stimulant commonly found in sports supplements but often labeled as an extract of geranium plants.

DMAA, which commonly goes by other names including 1,3-dimethylamylamine and methylhexaneamine (MHA), is not authorised for use in food supplements in the European Union, but is included in many weight loss and body building products – usually labeled as geranium extracts.

Products like USPLabs’ ‘Jack3d’ are being sold on many retail websites across the EU even though the product lists 1,3-dimethylamylamine on its ingredients panel, which it states is derived from ‘geranium stem’.

The situation prompted one Italian-based commentator at the recent NUCE trade event in Milan to wonder why authorities in his country are not taking some form of action.

“Of course the problem is that DMAA and geranium oil – even the natural form – cannot be used in Italy in food supplements,” he said. “But nothing is being done so far.”

Jack3d, which boasts it can, “produce an intense sensation of drive, focus, energy, motivation & awareness” and “allows for rapid increases in strength, speed, power and endurance” is being sold for around €30 on Italy’s second most popular online retail site for food supplements.

The situation is known to be under investigation by at least one European trade body and it has crossed the radar of the EU-funded botanical research project, PlantLIBRA.

Source

There is an ongoing debate, especially in North America, about whether DMAA, first manufactured synthetically by drug giant Eli Lily in the 1940s and trademarked as Forthane in 1971, is in fact a constituent of geranium, with the consensus growing that it is not.

Health Canada in August issued a statement that DMAA is not found naturally in geranium in affirming that any products containing it require a drug authorisation. But the US Food and Drug Administration (FDA) is yet to act on the matter, whilst trade groups are conducting research of their own.

While the legality is somewhat grey, the labeling practice hinges on the fact that a natural substance may be permissible in food supplements; a synthetically manufactured substance not so unless it has an explicit authorization. Yet in many jurisdictions, including the US, natural extracts also require authorisations.

Doping

DMAA and geranium extracts are banned by the World Anti-Doping Agency (WADA) and there have been doping violations, some of which are in process, and which may bring the possible adulteration issue to the public eye at greater intensity than has occurred to date.

US tennis professional Robert Kendrick was banned for 12 months earlier this year after testing positive for ‘geranium’ after taking a Jack3d-like product containing 1,3-dimethylamylamine.

"This is being sold as an otherwise safe and legit dietary supplement," said Travis Tygart, head of the US Anti-Doping Agency (USADA), of DMAA. "It's not. It's had tragic results to athletes. And there's a whole population of consumers who have no clue."

Many in industry would like to see DMAA removed from products because they fear misuse of the potent stimulant may lead to serious injury as happened with another potent herbal stimulant, ephedrine, before the US FDA banned it in 2003. It remains banned in most countries.

However, a search of the FDA adverse event report (AER) database reveals no DMAA-linked events in 2008 and 2009.

Present in geranium?

According to a single analysis by Chinese researchers reportedly using gas chromatography – mass spectrometry (GC-MS) techniques and published in the Journal of Guizhou Institute of Technology (1996, Vol. 25, pp. 82-85), DMAA is a constituent of geranium oil, but no other published analysis has reported its presence.

Health Canada criticised the Chinese paper for containing ‘errors’, and noted at least seven other papers found no DMAA in geranium oil.

The agency said, “there is no credible scientific evidence that DMAA is captured as an isolate of a plant … and therefore cannot be classified as a natural health product.”

Ed Wyszumiala, the general manager of dietary supplement programs at NSF International, told NutraIngredients-USA at the time: “This again shows that DMAA is an active pharmaceutical ingredient (API) and not a dietary ingredient.”