The Therapeutic Goods Administration (TGA) has clarified that state and territory governments will continue to be responsible for regulating fluoride in reticulated drinking water (‘tap water).
Legislative amendments made on 11 July 2019 put an end to any uncertainties about regulatory responsibility by explicitly excluding fluoridated drinking water from the scope of Australia’s therapeutic goods legislation.
In Australia, the Therapeutic Goods Act 1989 sets out the legal requirements for supplying therapeutic goods, such as medicines and medical devices. Following an amendment to the Therapeutic Goods (Excluded Goods) Determination 2018, fluoridated water is now an ‘excluded good’ for the purposes of the Act. The exclusion applies for any reticulated drinking water that contains fluoride, regardless of the original source of the fluoride.
Adjusting the level of fluoride in drinking water is a safe and effective way of preventing tooth decay in the community. In Australia, state and territory water authorities adjust the amount of fluoride in community water supplies using strict controls, which are set out by regulations in each jurisdiction. The National Health and Medical Research Council (NHMRC) has also stated ‘there is no reliable evidence of an association between community water fluoridation at current Australian levels and any health problems.’ Thus there is little risk that fluoridated reticulated drinking water would cause harm to the public if it were not regulated by the TGA.
State and territory governments established regulations for drinking water fluoridation as early as 1957, all before the Therapeutic Goods Act 1989 came into force. State and territory regulations are appropriate, so there is no need to apply a national system of control. There is no indication in the Therapeutic Goods Act 1989 that it was intended to apply to fluoridated drinking water. By specifically excluding fluoridated drinking water from the scope of the Act, ambiguity has been removed.
