The Federal Court of Australia has ordered Evolution Supplements Australia to pay $11 million for unlawfully advertising a range of unapproved sports supplement products, including references to steroids, Selective Androgen Receptor Modulators (SARMs) and pre-workout products containing DMAA and other amphetamine derivatives, in breach of the Therapeutic Goods Act 1989.
The Court also ordered Mr Cumhur Keskin, the Director of Evolution Supplements, to pay $1 million in penalties for failing to comply with an advertising direction issued by the TGA and failing to prevent Evolution Supplements' breaches of the Act.
These penalties are the largest ever imposed by the Federal Court in relation to contraventions of the Therapeutic Goods Act 1989 (Cth).
This decision follows the Court's finding earlier this year that Evolution Supplements and Mr Keskin unlawfully advertised prescription-only substances, products containing prohibited (Schedule 10) substances and medicines that had not been listed or registered by the TGA.
Mr Keskin also failed to comply with a TGA direction to stop advertising. Evolution Supplements tried to conceal its unlawful advertising by telling the TGA that it had taken the advertising down, but then continued to advertise some of its most dangerous products outside ordinary business hours.
"The substantial penalties imposed by the Court reflect the very real dangers to public safety from Evolution Supplements' conduct," TGA head Adjunct Professor John Skerritt said.
"The penalties imposed against Evolution Supplements and Mr Keskin send a strong message to businesses and their senior officers that there are significant consequences for unlawfully advertising dangerous sports supplements".
SARMs such as those advertised by Evolution Supplements has been linked to liver failure and increased risk of heart attack and stroke and have not been approved for human use.
The Court accepted evidence that SARMs present 'a serious risk to human health and safety, if not used within the TGA framework', and that the use of DMAA and Cardarine in supplements 'constitutes a serious risk to human health and safety'.
The Court also found that the breaches were 'very serious' noting that 'there were an extremely large number of contraventions over a sustained period of time, all of which took place after the Secretary had given clear notice that by advertising the impugned products Evolution was acting in breach of the terms of the TG Act...'
Evolution Supplements and Mr Keskin have also been ordered to pay the Department of Health's costs relating to the court proceedings.
Therapeutic goods must be entered in the ARTG before they can be lawfully supplied or advertised in Australia unless an exception applies. The Act also prohibits the advertising of prescription-only substances.
There are serious consequences for failing to comply with the advertising requirements for therapeutic goods and any direction from the TGA to address non-compliant advertising. This includes being issued with infringement notices, being charged with criminal offences or having civil court proceedings commenced against them.