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Case study: Food-medicine interface
About the advertising
On 21 February 2019, the TGA received a complaint about advertising by a nutrition company for therapeutic goods positioned as sports supplements.
The company advertised its products on its website, including reviews, testimonials and blog posts, along with podcasts via social media platforms including YouTube and SoundCloud.
The company sponsored one therapeutic good entered in the ARTG, however, the advertising for most of its products (some of which were described as 'formulated supplementary sports foods') included claims of a therapeutic nature. Following a review of the company's advertising, the TGA identified multiple therapeutic goods that were not entered in (or exempt from the need to be entered in) the ARTG.
These products included Prototype 8, Subcut, BlockE3, Alpha Venus, T432 Plus, AJpha Mars and Aurum Oil. The TGA also noted that advertising for Capzea, which was in the ARTG was not consistent with the indications in its listing and made claims of efficacy beyond those permitted.
Details of non-compliance
Advertising for Cort Rx and Alpha Mars included references to managing 'depression', which is a prohibited representation regarding the treatment of mental illness. The TGA had not authorised the use of this representation and therefore this was alleged to breach section 42DLB(2) of the Act.
Advertising for Resilience included references to the treatment of autoimmune conditions, which as a serious form of a disease, condition, ailment or defect, is a restricted representation. There was no TGA authorisation to make this reference in advertising for any of these products, in alleged breach of section 42DLB(4) of the Act.
After initial engagement by the TGA, the company continued to advertise 13 therapeutic goods not entered in the ARTG, allegedly breaching section 42DLB(9) of the Act. These were AMP-V, Alpha Mars, Alpha Prime, Alpha Venus, Aurum Oil, Block E3, Cort Rx, Multifood, Prototype 8, Resilience, Subcut, T432 Plus and ZMST.
The TGA alerted the company to the presence of non-compliant advertising content on its website and advised to have it removed.
The company confirmed it had amended its non-compliant advertising for Capzea, updating its product description, reviews and testimonials for consistency with indications in the ARTG listing. As a result, no further action relating to Capzea was required.
However, the company did not take sufficient action to address the other outstanding issues. As such, the TGA issued 24 infringement notices totalling $302,400 for 21 counts of advertising therapeutic goods not on the ARTG, two counts of using a prohibited representation and one count of using a restricted representation without TGA authorisation. The company accepted and paid these infringement notices.
Further, the TGA accepted a request from the company to enter into an enforceable undertaking, which is a type of regulatory action that is an alternative to the pursuit of court action. The undertaking included a list of stringent requirements for the company to introduce defined compliance activities and demonstrate ongoing compliance with therapeutic goods legislation. Enforceable undertakings are enforceable by courts.