Experimental medicines unlawfully advertised

The Federal Court has found that a supplements company and its director unlawfully advertised Selective Androgen Receptive Modulators

Evolution Supplements Australia Pty Ltd, and its sole director, Mr Cumhur Keskin, unlawfully advertised prescription medicines as well as therapeutic goods not listed in the Australian Register of Therapeutic Goods, to consumers, the TGA has said in a statement.

The Court made these findings on the basis that the company and Mr Keskin were taken to have admitted the TGA’s allegations, by failing to take appropriate steps to respond to or defend the proceeding.

There is no person listed by AHPRA by that name as being registered for any of the health professions requiring registration.

Advertising by Evolution Supplements Australia and Mr Keskin promoted SARMS, which are experimental medicines, among other dangerous substances.

The TGA notes that 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 judgement, made this month, prevents volution 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 TGA notes.

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.

Penalties are yet to be decided and a further hearing is to be held.

The TGA issued a reminder that any person, including any business, which advertises therapeutic goods must comply with the requirements.

“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.”

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