$11m unlawful advertising penalty sets a record

A supplier of unapproved sports supplements has been told to pay $11 million, as the TGA points out their potential to damage health

The Federal Court of Australia has ordered Evolution Supplements Australia Pty Ltd 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 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.

According to the Department of Health, 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,” said TGA head Adjunct Professor John Skerritt.

“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(link is external) 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.

Friends of Science in Medicine’s Dr Ken Harvey had written on Medreach.com.au that the complaint about Evolution Supplements had been worked up by one of his 2018 summer school students, Lucy Romanoff.

It had been submitted in December 2018 and on 30 March 2019, and 8 August 2019, Dr Harvey complained that the supplements and comparable products were still being advertised.

“Whacko!” he said after the TGA issued a statement about the $11 million fine. “It’s only taken three years!!”

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1 Comment

  1. Prof Paul James Brent

    Dr Harvey’s reaction about taking 3 years is disappointing. He should understand that the preparation of the risk assessment on the 97 products was a mammoth task. The first and supplementary reports ran to almost 300 pages and required comprehensive research on the available data. This task took considerable time to get right. Then there was the Court process which also takes time to get rfght. “Wacko”.

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