Fluoridated water not the TGA’s remit


water going down sink tap drip

The TGA has issued a clarification saying that state and territory governments will continue to be responsible for regulating fluoride in 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,” the TGA said in a statement.

The Therapeutic Goods Act 1989 saw an amendment to the Therapeutic Goods (Excluded Goods) Determination 2018 which means fluoridated water is now an “excluded good” for the purposes of the Act, the TGA advises.

“The exclusion applies for any reticulated drinking water that contains fluoride, regardless of the original source of the fluoride,” it says.

The TGA notes that 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,” it says.

“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.”

The TGA highlights that state and territory governments established regulations for drinking water fluoridation as early as 1957 – before the 1989 Act came into force.

“State and territory regulations are appropriate, so there is no need to apply a national system of control,” observes the TGA.

“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.”

Fluoridated water has been particularly controversial in Queensland, due to what the state branch of the Australian Medical Association has called an “impasse” between local Councils and the State Government.

Some major Councils voted to become fluoride-free following a 2012 legislative change which allowed them to stop fluoridating the water supply.

In March 2019, AMA Queensland president Dr Dilip Dhupelia wrote to Premier Anna Palaszczuk to say that her refusal to legislate for fluoride in all drinking water was disappointing and in denial of “overwhelming” evidence that the process was proven to be safe and effective as a preventive health measure.

Shortly before Dr Dhupelia penned the letter, Grattan Institute data revealed Queenslanders have the worst oral health in the country.

It found 20.5% of Queenslanders missed out on dental care because they could not afford private treatment and that pressure on the public system from a lack of fluoridation led to long waiting lists.

The most recent Queensland Health oral health services data showed 43% of children aged five to six years and 55% of those aged 5-14 had experienced dental decay, with the figure rising to 70% for indigenous children.

The 2018 Report of the Queensland Chief Health Officer found children accounted for one quarter of all hospitalisations for dental conditions.

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