Weight loss and hangover cures are amongst the ‘priority 2’ category of Therapeutic Goods Administration’s (TGA) watch on non-compliant advertisements, together with medicinal cannabis and therapeutic goods used in the cosmetic and beauty industry.
Therapeutic goods associated with COVID-19 are TGA’s current topmost priority in its clampdown of non-compliant advertisements.
Listing down the priorities would allow the TGA to focus its regulatory efforts on where “the highest risks to consumer health and safety were identified” based on feedback from the community, co-regulators, industry partners, and monitoring activities etc, the TGA said in a recent report.
In its latest inspection period, which was between July 2020 to June this year, there were a total of 2,074 reports on non-compliant therapeutic goods advertisements, about 153 less than year 2019/2020.
Over half (55 per cent) of the reports came from consumers, followed by the industry (18 per cent) and others such as health practitioners, regulatory consultants, and government body.
Concerning weight loss and hangover cures, the TGA had received 27 and nine non-compliant advertising reports respectively between November last year and June this year.
The most common problem with therapeutic goods advertising was the promotion of illegal therapeutic goods – meaning the goods were not listed in the Australian Register of Therapeutic Goods (ARTG).
For example, Melbourne-based online retailer CW IP had advertised Fatblaster Clinical capsules – which was cancelled from the ARTG on Dec 2019 – on Chemist Warehouse and My Chemist websites.
Sydney-based Cat Media also advertised FatBlaster Original on its website even after the product was removed from the ARTG.
In response, the TGA had issued notices to these advertisers, and most were said to have complied, but some went on to republish the non-compliant advertisement.
An example is CW IP, which republished non-compliant advertisements on four URLs of Chemist Warehouse and My Chemist.
Eventually, TGA issued four infringement notices totalling AUD$53,280 (US$38,825) to CW IP, which it paid in April this year.
“The TGA has re-evaluated advertising of unlisted weight loss products online and identified a marked reduction in non-compliant advertising of these products.
“Further follow-up action is underway and escalated regulatory action is possible. It is important that both sponsors and retail advertisers exercise due diligence in ensuring that their advertising of therapeutic goods complies with the regulatory framework,” the TGA said.
Other advertising problems included the unauthorised use of prohibited and restricted representations when advertising a product, and advertising products containing ingredients listed in schedule 3,4, or 8.
Is it food…or is it medicine?
The regulator also highlighted instances when a product should be regulated as a therapeutic good but was advertised as a food product.
The case in point involved a series of products under the ‘Doctor’ series, including ‘The Brain Doctor’, ‘The Adrenal Doctor’, and ‘The Gut Doctor’.
“To ascertain if the products would be correctly categorised as foods or therapeutic goods the TGA conducted a Food-Medicine Interface (FMI) assessment. This involved evaluating potentially applicable Food Standards or whether there is a tradition of use as a food for the goods in the form they were presented…
“In this case, it was determined the goods were not foods and were therefore therapeutic goods within the TGA’s jurisdiction,” said the TGA.
The products, which came in powder sachets, were from Australian firm Marco Mike. The products also made several health claims related to the nervous system, immunity, and irritable bowel syndrome.
“These factors contributed to the decision that these products were more likely to be therapeutic goods and not foods. A search of the ARTG did not identify any products listed under the brand names presented.
“As it was considered reasonable to assume that the advertiser may not have been aware of the regulatory requirements for therapeutic goods, the TGA wrote to the advertiser explaining how Food-Medicine Interface products are assessed by the TGA and provided details about how these particular products had been assessed by the TGA as being therapeutic goods.”
The advertiser, who was requested to cease the advertisements, had promptly complied with the request, the TGA said.
A check on the company found that one of the products has been relaunched as an ARTG-listed product and is now marketed under the name “Macro Brain.”