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Case study: Weight loss products
About the advertising
On 11 July 2018, the TGA received a complaint about weight loss and related health benefit claims made in the advertising for FatBlaster Clinical, a listed medicine.
The advertising elements communicating these claims included the product name, imagery, packaging, website and other promotional information.
The TGA requested the product sponsor to provide the information it held to substantiate the therapeutic claims made and to support the indications entered in the ARTG for the product. On review of the evidence provided, the TGA determined that the clinical studies were not sufficiently rigorous to substantiate the disputed claims. Of the two studies provided by the sponsor as the primary sources of evidence:
- both were conducted over a short duration and failed to demonstrate meaningful weight loss results
- both were conducted outside Australia and neither could demonstrate that the study population was similar to the composition of the Australian population
- the authors of one study were employed by companies with significant interests in the results of the study, and
- secondary sources of evidence provided were insufficient on their own to support specific indications.
In response, the sponsor updated its promotions to replace claims regarding weight loss with those relating to weight management. However the product name and weight loss indications in its ARTG listing remained unchanged, which were not supported by the evidence provided.
Details of non-compliance
Since the evidence provided by the sponsor was not satisfactory, the TGA considered that the weight-loss claims were unsubstantiated. These claims were inaccurate, likely to mislead and exaggerate product efficacy, breaching sections 9(a), 9(b) and 10(a)(ii) of the Code.
The overall presentation of the product was considered misleading (also section 9a of the Code), with the terms 'FatBlaster' and 'Clinical' together with imagery of a slim person and a measuring tape suggesting that consumers could achieve significant weight loss with the use of the product, consistent with results purportedly demonstrated through clinical trials.
In addition to reinforcing the unsubstantiated weight loss claims, the imagery used did not reflect the results that the average user could expect to achieve from using the product. It implied that the individual portrayed by the image has used the goods and has achieved significant weight loss, with a significant reduction in waist circumference. This was not consistent with the evidence provided, therefore breaching section 26(3) of the Code.
The TGA liaised with the sponsor to highlight the areas of compliance that needed attention and consider alternate proposals from the sponsor.
However, a satisfactory proposal was not received and, on 20 November 2019, the TGA notified the sponsor of the decision to cancel the product from the ARTG and issued a direction notice to cease making product claims relating to weight loss, including use of the misleading product imagery. The product's entry in the ARTG was cancelled on 20 December 2019.