Complementary medicines advertising policy Part II: unethical conduct in the Australian market after July 2018.

Objective. To assess the effects of Australian complementary medicines advertising policy after major changes in 2018. These included a legally enforceable advertising code, stronger investigative and compliance powers for the Therapeutic Goods Administration (TGA) and enhanced educational resources for industry. Methods. Analysis of the TGAcomplaint outcome database from 1 July 2018 to 30 June 2019 and the new regulatory measures. Results. Of 1821 complaint records analysed, 92% were classified as low priority and closed by sending the advertiser a Regulatory Obligation letter. For low priority complaints, no details of the product, advertiser or alleged Code violation were published, and no follow-up was undertaken. Of 121 higher priority complaints, 79% failed to meet their key performance indicator (KPI) time to closure (60-90 days). These included complaints about dangerous sports supplements and ineffective weight loss and hangover products, some of which had been submitted in July 2018. Conclusions. Complaint classification and actions taken by the TGA were inconsistent. The TGA's new compliance powers were rarely applied. The new complaint system is less transparent than the one it replaced. There is a high rate of advertising complaints and a low rate of effective regulatory response. Time-based KPIs should be based on outcome measures, not when a case is closed by a process measure. An urgent review of the new system is required. Comment on Australia's 2018 Royal Commission into Misconduct in Banking is equally applicable to the TGA: 'Essentially a failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that.' It also encourages others to break the law, leading to a race to the bottom and consumer detriment. [ABSTRACT FROM AUTHOR]