After several consultations the TGA concluded DMAA (methylhexaneamine/1,3-dimethylamylamine) – a stimulant commonly used in pre-workout products like Napalm, Crack and Jack3D – was a prohibited substance on several grounds including:
- “there are no current approved therapeutic uses for DMAA;
- there are no benefits but there are significant risks;
- there are risks due to DMAA's toxicity;
- DMAA presents a high risk of abuse, misuse and illicit use;
- reports of adverse events including high blood pressure, psychiatric disorders, cerebral haemorrhage and stroke;
- an absence of studies demonstrating the long-term safety of DMAA;
- the wide variability in the potency of the different doses of DMAA.”
The ban will be effective from August 1 - in about two weeks.
The TGA states substances on the Schedule 9 list, “may only be used for research purposes. The sale, distribution, use, and manufacture of such substances without a permit is strictly prohibited by law.”
Previously the country’s Advisory Committee on Medicines Scheduling (ACMS) recommended against placing DMAA on Schedule 9 list because it said there was, “inadequate evidence to suggest DMAA's toxicological and pharmacological properties”.
It also noted DMAA was not listed in Schedule IV to the United Nations Convention on Narcotic Drugs, 1961 or in Schedule 1 to the United Nations Convention on Psychotropic Substances, 1971.
It found DMAA did not require the same level of control as amphetamine.
The TGA took that advice onboard but noted the April decision by New Zealand to mark DMAA as a narcotic along with warnings issued in the US, Canada and the UK in coming to its verdict.
In a public consultation period leading up to the decision, five comments were received from parties whose identities were not revealed.
One opponent said: “As an Australian I am really appalled that both New Zealand and the US have banned this ingredient before Australia. Especially when there were so many people like myself that spoke up years ago about this.”
“If up to me you couldn't ban DMAA quick enough. Tomorrow is too late.”
But a supporter wrote: “I believe the DMAA when used in correct dosage is 100% safe and effective. This is evident by the fact it has been around for 6 years and there have been no negative effects conclusively linked to the ingredient, whereas in the same period alcohol, tobacco and obesity has killed a countless amount of people.”
“So, I oppose this ban, I believe being stricter on quality and quantity would be more suitable for this ingredient. Otherwise, why not ban caffeine and vitamin B next?”
Other countries to ban DMAA include Ireland, Sweden, Denmark and Finland and Italian and French authorities are said to be about to move against it.
Irleand recently named and shamed products including Hemodrene; Hemorush; Hemo-Rage; Marrow Matters; Spriodex and Lipo-6 Black.
One of the issues around DMAA is whether it is sourced from the geranium plant or not. Two recent studies have added to a body of evidence that says it is not but USP Labs – the maker of the Jack3D - has sued retailers for making disparaging remarks about Jack3D and DMAA, and says it is about to produce evidence that shows DMAA is present in the plant.
Food Standards Australia New Zealand (FSANZ) last month issued an alert about DMAA. “Consumers that have purchased the sports food products ... should not consume the product and discard it," said FSANZ deputy chief executive officer, Melanie Fisher.
The TGA decision can be found here.