Several countries have, in recent months, cracked down on the manufacture, supply and sale of products containing methylhexaneamine (MHA) as dietary supplements, leading to speculation that the substance may no longer be available as an across-the-counter nutritional aid.

Last month, the Medicines and Healthcare products Regulatory Agency (MHRA) of the U. K., ruled that products containing methylhexaneamine needed to be removed from the UK market because of “potential risks to public safety.”

Stimulant

The drug, also known by several other chemical names, including dimethylamylamine (DMAA), is an ingredient of many dietary supplements that are used by sportspersons. Other supplements have also been found contaminated often with this drug which is categorised as a stimulant and banned by the World Anti-Doping Agency (WADA).

It has been claimed during the past few years that MHA was derived from the geranium plant, especially its oil and root extract. Being a natural substance, and as part of dietary supplements, it escaped regulations applicable to drugs in several countries.

One of the most popular products containing MHA, Jack3D, produced by USP Labs, Dallas, Texas, has been ordered to be removed by retailers, among other supplements, by the MHRA, UK. In a release dated August 28 last, the MHRA stated that Jack3D was an “unlicensed medicinal product”.

The UK decision followed a similar action by the Therapeutic Goods Administration (TGA), Australia, early last month banning the use of DMAA which is also considered as a ‘party drug’.

Toxic substance

“The TGA urges people not to obtain, supply or use DMAA. DMAA is a toxic substance with dangerous side effects. Buying such substances over the internet is risky.”

The TGA statement said that on August 2 last, the Western Australia State Coroner found that a mine worker had died from taking DMAA, which he had bought over the internet. The TGA ban includes personal use of DMAA, whether “bought over the internet or not”.

The Food and Drug Administration (FDA), USA, issued warning letters to 10 manufacturers of dietary supplements including USP Labs, last April stating that they were marketing the products without having submitted evidence of their safety to the FDA.

The FDA said in a release that since such manufacturers had not submitted evidence of safety, products containing DMAA would be considered as “adulterated”. The FDA move followed a decision of the US Department of Defence that temporarily banned the sale of products containing DMAA within military facilities following deaths of two soldiers suspected to be due to DMAA use.

Health Canada had categorised DMAA as a medicinal product as far back as August 2011, and stated that any product containing DMAA required authorisation from Health Canada as a drug in order to be sold legally in Canada.

Industry’s take

The MHA supplements industry has repeatedly stated that the products are safe and they actually contain natural ingredients. The claim that geranium oil contained MHA, as reported in a single research by a group of Chinese scientists in 1996, has since been challenged by a few other studies notably by a group of Australian scientists in 2011.

Health Canada stated last year that there was no credible scientific evidence to show that DMAA had been “captured as an isolate of a plant”.

Without verification by competent authorities, and mainly based on internet searches, many so-called ‘experts’ in India had branded MHA as an ingredient of geranium oil since it was brought into the Prohibited List in January 2010. It was also suggested that massaging with geranium oil or using lotions, soaps or face-packs containing the substance could trigger a ‘positive’ test for MHA.

No regulation in India

There is no regulation in India to oversee supplements distribution or sale. A number of foreign products are available in the market and are often sold near gyms, and at venues holding sports events. These arealso available on the internet.

A spokesman for the Food Safety Standards Authority of India (FSSAI) said on Tuesday that regulations for supplements distribution in the country could soon be in the offing.

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