From July 2018 to July 2019, complaints about a convenience sample of twenty-one complementary medicine weight loss products, by eight sponsors, advertised on 140 different Internet sites (cases) were submitted to the TGA. FatBlaster products sponsored by Cat Media (Naturopathica) were highlighted. It was alleged that all these advertisements breached the Therapeutic Goods Advertising Code.
The complaints and their TGA reference numbers follow:
- 6 July 2018, Pharmacare Laboratories FatBlaster FatMagnet products, AC-GBKDH2XG/2018.
- 16 August 2018, Pharmacare Laboratories Weight Loss Products, Additional information requested, AC-NJ15VLQ9/2018
- 21 March 2019, Blackmores Ltd – Metabolic C12, AC-K1XPSTXI/2019.
- 29 July 2019, 103 breaches of the Therapeutic Goods Advertising Code (No. 2) 2018, s.26(3)(a) by 35 companies advertising 19 weight loss products, AC-MBNGMHNQ/2019.
These complaints were followed up in July 2020 by Monash Work Integrated Learning (WIL) students. They found that all products complained about in 2018-2019 continued to be promoted at that time. They conducted a literature review and found (as have others) there was no evidence to support the claims made for complementary medicine weight loss products.
The complaints were reviewed again in February 2021. A detailed Excel file of the findings can be downloaded here; also, a PDF of the images of all products complained about in 2018-19, still advertised in 2021. An example follows:
All twenty-one complementary medicine weight loss products complained about in 2018-19 were still being advertised on February 17, 2021.
This was despite three products being cancelled from the ARTG by the TGA (‘Healthy Care Forskolin’, ARTG no 226073 on 8 Mar 2016; ‘FatBlaster Clinical’, ARTG no. 295575 on 20 Dec 2019 and ‘FatBlaster FatMagnet’, ARTG no 145959 on 23 Dec 2020). At least six other products had also been cancelled by the sponsor but were still being advertised. These included FatBlaster Triple-Tea Fat Burner, the only one that the TGA gently chastised Cat Media about.
One reason that sponsors cancel listings themselves is to abort TGA post-market compliance reviews. The TGA assesses around 160 listed products a year (out of more than 10,000). The results can be found (with difficulty) in TGA annual performance statistics reports. Over the last five years, on average, around 75% of products assessed have been found non-compliant, mainly because companies are unable to produce evidence to substantiate claims for efficacy. In 2018-20, 15% of 376 reviews were cancelled by sponsors following a request for information by the TGA.
Once cancelled, a therapeutic good can no longer be imported, manufactured, or exported from Australia, but it can be sold until the stocks run out. Advertising a product not on the ARTG is a serious breach of the Therapeutic Goods Act, but it appears that the TGA (and most advertisers) do not check ARTG cancellations to see if this is occurring. Advertisements for these products provide no indication that they have been delisted.
Another response to cancellation of a product by the TGA is for the sponsor to relist comparable products. For example, ‘FatBlaster Clinical’ (currently still being sold) was replaced by ‘FatBlaster Platinum + Thermoburn’ and ‘FatBlaster Platinum Metabolism’. The cancelled ‘FatBlaster FatMagnet also has a new listing: ‘FatBlaster FatMagnet Max’ with a new ingredient (Opuntia ficus-indica) that also doesn’t work. Ironically, the TGA publicised their cancellation of FatBlaster Clinical but failed to act on the products that replaced it, despite their presentation also appearing to breach the Code.
TGA action (albeit limited) appears to have eliminated the imagery of slim people on eleven weight loss products; however, ten remained unchanged.
There are at least 31 permissible indications that facilitate the proliferation and promotion of ineffective weight loss products. They include, ‘Helps regulate appetite’, ‘Promote/enhance feeling of satiety’ and ‘Enhance/promote/increase temporary weight loss’. The latter was added on 21 January 2021. The type of evidence required was said to be ‘scientific’ and an accompanying mandatory label statement stated, ‘Weight loss may not be maintained for longer than 3-months’. This indication appears irreconcilable with the TGA 2019 ‘Guidelines on the evidence required to support indications for listed complementary medicines relating to weight loss products’. For weight loss indications and scientific evidence this document states, ‘the study duration is a minimum of 6-months’.
There has also been a move by sponsors to the use of ‘traditional’ rather than ‘scientific’ evidence and to reformulate weight loss complementary medicines as food shakes to take advantage of the food-medicine regulatory divide.
In conclusion, it is hard to understand why the TGA has failed to act on this public health problem. They have also failed to act on other public health problems, such as hangover products. The TGA’s inaction leaves it open to claims it prioritises industry profitability over consumer protection. Yet another complaint has been submitted to the TGA about these ongoing matters (AC-OD3FYZZ4/2021, 19 Feb 2021); followed-up 24 Feb 2021, AQ-JY6VZ5LA/2021 as no acknowledgment).
- ARTG cancellations by the TGA
- ARTG cancellations requested by the sponsor
- Advertising Complaints and Investigations Database
- Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021
- Unnecessary, expensive, and potentially dangerous supplements consumed by older Australians
- TGACC presentation 17 Oct 2019
- TGACC presentation 20 Feb 2020
- Skepticon presentation 24 Oct 2020
- Resignation from TGACC