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 TGA complaint 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. What is known about the topic? The previous co-regulatory system for complementary medicines was the subject of long-standing criticism and high levels of regulatory non-compliance. The new system, operated solely by the TGA, was meant to overcome these problems. What does this paper add? High levels of advertising complaints persist. The TGA was unable to close many higher-priority complaints within the time frame set by its KPIs. These complaints involved serious breaches of the Therapeutic Goods Act 1989 (Cwlth), which can attract both civil and (strict liability) criminal penalties. However, in most cases compliance was achieved by negotiation. The TGA met its KPIs for virtually all complaints it classified as low priority because these were closed by merely sending an obligations letter with no follow-up. What are the implications for practitioners? The persisting high levels of regulatory violation mean that practitioners cannot trust the claims made for complementary medicines or give good advice. In addition, consumers are wasting their money on useless products and are diverted from seeking more evidence-based remedies.