The Federal Court of Australia (the Court) has found that Evolution Supplements Australia Pty Ltd (Evolution Supplements Australia) and its sole director, Mr Cumhur Keskin, unlawfully advertised prescription only substances and therapeutic goods not in the Australian Register of Therapeutic Goods (ARTG) to consumers. The Court also found that Mr Keskin had failed to comply with a direction from the Therapeutic Goods Administration (TGA), part of the Department of Health, to stop advertising these goods.
The Court made these findings on the basis that Evolution Supplements Australia and Mr Keskin were taken to have admitted the allegations made by the TGA by failing to take appropriate steps to respond to or defend the proceeding.
Under the Therapeutic Goods Act 1989 (the Act), therapeutic goods must be entered in the ARTG before they can be lawfully supplied or advertised in Australia. (There are some limited exceptions to this requirement however, they did not apply in this case.) The Act also prohibits consumer advertising for substances, including goods containing substances, in Schedule 4 of the Poisons Standard (prescription only substances). The TGA takes breaches of these requirements seriously, as using prescription only substances without appropriate medical supervision may result in serious harm to consumers.
Advertising by Evolution Supplements Australia and Mr Keskin promoted Selective Androgen Receptor Modulators (SARMs), amongst other dangerous substances. SARMs are experimental medicines, and no SARM has been 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 Court’s judgment, on 8 February 2021, prevents Evolution Supplements Australia and Mr Keskin, for a period of five years, from engaging in consumer advertising for prescription only substances or therapeutic goods that are not entered in the ARTG. Failing to comply with an injunction results in a contempt of court-a serious offence that can result in imprisonment. The Court also ordered that Evolution Supplements Australia and Mr Keskin pay the costs related to the court proceedings to date.
The Court’s judgment comes after the Department of Health commenced Court proceedings in March 2020 against Evolution Supplements Australia and Mr Keskin for alleged breaches of the Act and failing to comply with the direction issued by the TGA. In April 2020, the Court granted an interim injunction to prevent Evolution Supplements Australia and Mr Keskin from advertising specified therapeutic goods.
A further hearing will be held to determine the penalties that should be paid in relation to this matter.
The TGA takes action against breaches of the Act
Any person (including any business), that advertises therapeutic goods to consumers must comply with the requirements for advertising. There are serious consequences for failing to comply with the requirements and any direction from the TGA to address non-compliant advertising.
Senior officers of companies advertising therapeutic goods should also be aware that, in some circumstances, they may be personally liable for unlawful conduct by the company if they are aware that the company will breach the law, were in a position to prevent that breach, and failed to take reasonable steps to do so.
The TGA encourages consumers to report suspected non-compliant advertising via its advertising reporting form.