On Thursday 30 May 2019, the Therapeutic Goods Administration (TGA) executed four search warrants connected to a business operating in the Sutherland Shire, Sydney. This was undertaken in conjunction with NSW Police, the Australian Federal Police (AFP), the Australian Taxation Office (ATO) and NSW Health.
During the search, various items were seized. These items allegedly include raw materials and finished Selective Androgen Receptor Modulators (SARMs), and Nootropic products. The products are not included in the Australian Register of Therapeutic Goods (ARTG) and therefore cannot be supplied in Australia. Documents, packaging materials, manufacturing equipment and advertising materials were also uncovered and seized.
The operation was part of an investigation into the alleged importation, advertising and supply of unapproved therapeutic goods, including scheduled medicines. Enquiries are still underway, including laboratory analysis of the seized goods, and further action will depend on the outcome of investigations.
What are SARMS?
SARMs are a group of experimental drugs, sometimes used illegally in the bodybuilding, image-enhancing and sport industries. SARMs are ‘Prohibited Imports’ according to the Customs (Prohibited Imports) Regulations 1956.
In 2017, the Food and Drug Administration (FDA) in the United States warned use of SARMs was linked to liver failure, and increased risk of heart attack or stroke. Other reported complications include jaundice, nausea and pain. There is also limited information on how SARMs interact with other medications or conditions. Because there is little clinical information about the use of these substances in humans, they may have other unknown health risks.
Some products sold as SARMs may have other potentially dangerous ingredients such as steroids. A study published in the Journal of the American Medical Association (JAMA) examined the contents of 44 products sold online as containing a SARM. This study found that only 52% of the products examined actually contained SARMs, and that 25% of the products examined contained an unlisted ingredient. Some products contained a different dosage to the one advertised, and some had no active ingredients at all.
TGA enforcement actions
The TGA oversees the regulation of therapeutic goods used in Australia, whether produced in Australia or elsewhere, or exported from Australia. The TGA uses a range of enforcement actions to address illegal supply of unapproved therapeutic goods, in the interests of public health and safety, including court-based outcomes. If an individual or company is identified as having committed an offence under the Therapeutic Goods Act 1989 (Cth), penalties can range from 12-months imprisonment and/or 1000 penalty units, to 5-years imprisonment and/or 4000 penalty units. An individual penalty unit is $210.