A review of proposals to reform the regulation of complementary medicines.

In 2003, the Therapeutic Goods Administration instituted a major recall of products made by Pan Pharmaceuticals Limited. Later that year, an expert committee produced 49 recommendations for complementary medicines reform, many of which were to be implemented by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA). In 2008, the Pan Pharmaceuticals affair reached some conclusion in the courts, the ANZTPA had been abandoned and the case for reform had intensified. There was widespread and increasing use of complementary medicines yet consumers were often unaware that, unlike conventional medicines, these medicines were not evaluated for efficacy. The justification of this two-tiered regulatory system was that complementary medicines are relatively low-risk products. However low risk does not mean no risk. A number of consumers have been shown to use these products for conditions where there is no evidence of effect, potentially placing them at risk. In addition, promotion often overstates their benefits while minimising and sometimes denying known adverse effects and drug interactions. Complaint procedures are overloaded and the "sanctions" available do not deter repeat offenders. A number of regulatory reforms have been suggested to overcome these problems; they are reviewed in this paper.