The Secretary of the Department of Health has commenced proceedings in the Federal Court of Australia (Court) against Evolution Supplements Australia Pty Ltd (trading as Evolution Supplements Australia) and Mr Cumhur Keskin, the sole director and secretary of the company, for alleged breaches of the Therapeutic Goods Act 1989 (the Act).
Evolution Supplements Australia and Mr Keskin are alleged to have advertised therapeutic goods not entered in the Australian Register of Therapeutic Goods (ARTG), including therapeutic goods that Evolution Supplements claims, in advertisements the subject of the proceedings, contain substances included in Schedule 4 and/or Schedule 10 to the Poisons Standard.
Schedule 4 substances are prescription only substances and their use should always be monitored by a doctor. Schedule 10 substances are those of such danger to health as to warrant prohibition of sale, supply and use.
It is also alleged that Evolution Supplements Australia and Mr Keskin continued to advertise the goods in question during 2019 despite both a warning letter and a formal direction being issued to Mr Keskin by the Therapeutic Goods Administration (TGA).
The advertising by Evolution Supplements Australia and Mr Keskin is alleged to have included references to Selective Androgen Receptor Modulators (SARMs).
SARMs are experimental medicines and no SARM has been fully researched, or approved for human use. The use of SARMS has been linked to liver failure and increased risk of heart attack and stroke. Importing, supplying or possessing SARMs without a valid prescription, license or authority is illegal.
The Department of Health seeks to protect the public from exposure to products of this kind. The Department of Health is taking this action due to the serious harm to consumers' health and safety that could result from use of these products particularly if they are used without adequate or appropriate medical supervision.
This legal action follows an investigation by the TGA in response to an advertising complaint.
The Secretary's application asks the Court to impose financial penalties, and to issue declarations and final orders requiring Evolution Supplements Australia and Mr Keskin to stop advertising therapeutic goods that are not listed or registered on the ARTG, and to remove from the relevant website any advertisements that refer to Schedule 4 substances.
Directors and senior officers of companies should be aware that the Act provides for senior corporate officers of a company to be held personally liable for contraventions of the Act by that company in specified circumstances.
The originating application and statement of claim filed in the Federal Court are available at:
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